Myeloma
Today
FALL 2010
Volume 8 Number 4
A Publication of the International Myeloma Foundation
Dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure.
Scientific & Clinical News
Supportive Care
The International Myeloma Working Group (IMWG)
Tiffany Richards, member of the IMF Nurse Leadership
convened its inaugural Myeloma Summit, a first-of-its-
Board (NLB) and leader of the NLB task force on sexuality
kind meeting. Nearly 70 of the world's leading experts in
and sexual dysfunction, answers questions about the dis-
multiple myeloma and related blood cancers, represent-
ruption of the sexual response cycle as a result of physical
ing more than 20 countries and over 30 institutions, met
illness or psychological factors. The discussion encompass-
to identify, support, and implement the most promising research to prevent
es the impact of disease and its therapies on sexual activity
the onset of active disease, improve treatment, and find a cure for myeloma.
and function, body image and psychological well-being,
As research data builds support for continuous myeloma treatment, the IMWG
treatment of sexual dysfunction, and fertility preservation. PAGE 10
is laying the groundwork to move beyond long-term remissions and begin
charting a roadmap for an actual cure.
IMF Hotline Coordinators respond to a
PAGE 5
question about bortezomib (VELCADE®).
Dr. Brian G.M. Durie offers a brief recap of the key
Effectiveness, dosing, infusion frequency,
presentations made at the 2010 annual meeting of the
potential side effects, and current clinical
American Society of Clinical Oncologists (ASCO), which
trial data related to this widely-used novel
was held June 48 in Chicago, IL. Dr. Durie answers
agent are discussed. Specific guidelines
questions about new data on the approved novel anti-
for determining bortezomib dose, soon to be published by the International
myeloma agents, new data on the two most promising
Myeloma Working Group (IMWG), are also summarized. PAGE 11
drugs in development plus agents in early develop-
ment, as well as advances in combination therapies.
Special Event
Dr. Durie also addresses a general shift of perspective among myeloma
Prof. Joan Bladé is honored with the Robert A. Kyle Lifetime
clinicians towards continuous treatment of the disease as a way to prevent or
Achievement Award for his body of work in myeloma.
delay disease relapse. PAGE 6
Prof. Bladé is Senior Consultant and Director of Myeloma
Prof. Meletios A. Dimopoulos
Programs at Hospital Clínic de Barcelona in Spain as well as
answers questions about
co-founder of the PETHEMA Foundation, co-founder of the
the challenges of treating relapsed and/or refractory
Spanish Myeloma Group, chair of the group that developed
multiple myeloma, the currently-available treatment
the European Group and Marrow Transplantation (EBMT)
options, and the role of emerging therapies in this
response criteria, member of the International Myeloma Working Group
setting. For patients with relapsed/refractory disease,
(IMWG), and author of more than 200 papers on myeloma.
there is an urgent need to develop targeted drugs that
PAGE 12
provide durable disease control and symptomatic relief.
Also in this issue...
Vorinostat, a histone deacetylase (HDAC) inhibitor that
has been shown to have activity in myeloma, is being investigated in two
Dear Reader by IMF president Susie Novis PAGE 3
major studies. Prof. Dimopoulos offers his assessment of this potential new
News & Notes PAGE 4
treatment option for patients with advanced myeloma. PAGE 7
International Affiliates PAGE 14
Dr. David S. Siegel shares his experience of working with
Spotlight on Advocacy PAGE 15
carfilzomib, a second-generation proteasome inhibitor,
and discusses how this new compound differs from
2010 IMF Annual Support Group Leaders' Summit PAGE 17
bortezomib (VELCADE®), the first proteasome inhibi-
Investing in the Future PAGE 18
tor approved for use in multiple myeloma. Data from
Member Events PAGE 19
clinical trials of carfilzomib is showing that it is at least
as effective against myeloma as bortezomib, has a bet-
IMF Staff Updates PAGE 21
ter toxicity profile, and may be active in patients who
2010 / 2011 IMF Calendar of Events BACK COVER
have become resistant to bortezomib. The phase I clinical trials of carfilzo-
mib showed that it was well-tolerated and was associated with low rates of
Looking for a LocaL myeLoma support group?
peripheral neuropathy (PN). PAGE 8
Please visit our website at www.myeloma.org or call the IMF at 800-452-CURE (2873).
This issue of Myeloma Today is supported by
Binding Site, Celgene Corporation, Millennium: The Takeda Oncology Company, Novartis Pharmaceuticals, and Onyx Pharmaceuticals.
Inter
P
nationallaceholder
Myeloma Foundation
Founder
President
Brian D. Novis
Susie Novis
Board of Directors
Chairman Dr. Brian G.M. Durie
Tom Bay
Michael S. Katz
Dr. Edith Mitchell
Matthew Robinson
Allan Weinstein
Loraine Boyle
Benson Klein
Charles Newman
E. Michael D. Scott
Amy Weiss
Mark Di Cicilia
Dr. Robert A. Kyle
Susie Novis
Igor Sill
Scientific Advisory Board
Chairman Robert A. Kyle, USA
Scientific Advisors
Raymond Alexanian, USA
Thierry Facon, France
Antonio Palumbo, Italy
Kenneth C. Anderson, USA
Dorotea Fantl, Argentina
Linda Pilarski, Canada
Michel Attal, France
Jean-Paul Fermand, France
Raymond Powles, United Kingdom
Hervé Avet-Loiseau, France
Rafael Fonseca, USA
S. Vincent Rajkumar, USA
Dalsu Baris, USA
Gösta Gahrton, Sweden
Donna Reece, Canada
Bart Barlogie, USA
Morie A. Gertz, USA
Paul Richardson, USA
Régis Bataille, France
John Gibson, Australia
Angelina Rodríguez Morales, Venezuela
Meral Beksaç, Turkey
Hartmut Goldschmidt, Germany
David Roodman, USA
William Bensinger, USA
Roman Hájek, Czech Republic
Jesús San Miguel, Spain
James R. Berenson, USA
Jean-Luc Harousseau, France
Orhan Sezer, Germany
Leif Bergsagel, USA
Joy Ho, Australia
Kazayuki Shimizu, Japan
Joan Bladé, Spain
Vania Hungria, Brazil
Chaim Shustik, Canada
Mario Boccadoro, Italy
Sundar Jagannath, USA
David Siegel, USA
Michele Cavo, Italy
Douglas Joshua, Australia
Seema Singhal, USA
J. Anthony Child, United Kingdom
Michio M. Kawano, Japan
Alan Solomon, USA
Raymond L. Comenzo, USA
Henk M. Lokhorst, The Netherlands
Pieter Sonneveld, The Netherlands
John Crowley, USA
Sagar Lonial, USA
Andrew Spencer, Australia
Franco Dammacco, Italy
Heinz Ludwig, Austria
A. Keith Stewart, USA
Faith Davies, United Kingdom
Jayesh Mehta, USA
Guido J. Tricot, USA
Meletios A. Dimopoulos, Greece
Hĺkan Mellstedt, Sweden
Benjamin Van Camp, Belgium
Johannes Drach, Austria
Giampaolo Merlini, Italy
Brian Van Ness, USA
Brian G.M. Durie, USA
Gareth Morgan, United Kingdom
David Vesole, USA
Hermann Einsele, Germany
Nikhil Munshi, USA
Jan Westin, Sweden
Amara Nouel, Venezuela
Headquarters
12650 Riverside Drive, Suite 206, North Hollywood, CA 91607-3421 USA
Tel: 818-487-7455 or 800-452-CURE (2873)
Fax: 818-487-7454
Email: TheIMF@myeloma.org Web: www.myeloma.org
IMF Staff
Executive Director
David Girard (dgirard@myeloma.org)
Chief Financial Officer
Senior Global Analyst
Senior Vice President,
Vice President,
Vice President,
Jennifer Scarne
Dan Navid
Strategic Planning
Development
Clinical Education & Research Initiatives
(jscarne@myeloma.org)
(dnavid@myeloma.org)
Diane Moran
Heather Cooper Ortner
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(dmoran@myeloma.org)
(hortner@myeloma.org)
(lpaik@myeloma.org)
Database & Inventory Control
European Programs
Regional Co-Director, Support Groups SE
Betty Arevalo (marevalo@myeloma.org)
Gregor Brozeit (greg.brozeit@sbcglobal.net)
Andrew Lebkuecher (alebkuecher@myeloma.org)
Director of Advocacy
Advocacy Grassroots Liaison
Specialty Member Services Coordinator
Arin Assero (aassero@myeloma.org)
Meghan Buzby (mbuzby@myeloma.org)
Kemo Lee (klee@myeloma.org)
Inventory Control Associate
Director, Support Groups Outreach
Director of Annual Giving and Social Media
Alci Avelar (aavelar@myeloma.org)
Kelly Cox (kcox@myeloma.org)
Randi Lovett (rlovett@myeloma.org)
Director of Member Events
Hotline Coordinator
Development Intern
Suzanne Battaglia (sbattaglia@myeloma.org)
Paul Hewitt (phewitt@myeloma.org)
Kerri Lowe (klowe@myeloma.org)
IT Consultant
Meeting & Event Services
Publication Design
Zsolt Bayor (zbayor@myeloma.org)
Spencer Howard (showard@myeloma.org)
Jim Needham (jneedham@myeloma.org)
Hotline Coordinator
Publications Editor
Data Specialist
Nancy Baxter (nbaxter@myeloma.org)
Marya Kazakova (mkazakova@myeloma.org)
Selma Plascencia (splascencia@myeloma.org)
Hotline Coordinator
Hotline Associate
Webmaster
Debbie Birns (dbirns@myeloma.org)
Missy Klepetar (mklepetar@myeloma.org)
Abbie Rich (arich@myeloma.org)
Regional Co-Director of Support Groups SE
Accountant
Regional Director, Support Groups NE
Joanie Borbely (jborbely@myeloma.org)
Phil Lange (plange@myeloma.org)
Robin Tuohy (tuohy@snet.net)
2
www.myeloma.org
A Message from the President
Dear Reader,
After 20 years of reaching out to patients and their families across America
No matter how much or how little time you
and around the world, I am saddened that many people still are not get-
have available, you can make a difference. An
ting the information they so desperately need. Every year, the IMF mails
hour a week, a day a month, whatever time
out over 20,000 Info-Packs that contain a wealth of information about
you can give will go a long way.
myeloma and its treatments. Our award-winning website www.myeloma.
org has everything you need to know about this disease, whether you're
I'm asking you to become an IMF volunteer
a patient, caregiver, doctor, nurse, or anyone touched by myeloma.
and help us help others.
From the IMF's toll-free Hotline 800-452-CURE (2873), Patient & Family
It can be as simple as placing our free infor-
Seminars, and Regional Community Workshops, to our conference calls,
mational materials especially our book-
webinars, and our work with over 100 support groups across the country,
marks printed with our toll-free Hotline number in hospitals, doctors
we have the most extensive reach in the myeloma community. But we're
offices, libraries, drug stores, senior centers, schools, or places of worship,
still not reaching everyone.
just to name a few.
Remember how you felt when you first heard the words "multiple
You can tell everyone you meet about the IMF Hotline. When myeloma
myeloma?" I remember how I felt: devastated, depressed, scared, and all
patients call the Hotline for the first time, you can almost feel them
alone. But it doesn't have to be that way. I am calling on each and every
breathing a sigh of relief, because finally they've reached someone who
one of you to help the IMF help others. Together we can help lift people
knows about their disease, who can answer their questions and provide
up and empower them. We can tell them about new treatments that can
guidance, and who really cares about them and their family.
put their myeloma into a very good remission. We can let them know that
You can help change a patient's outlook from fear and isolation to hope
they are not alone, and that across America and around the world there
for a brighter future, because
are people living well with myeloma.
you took the time to spread the word.
Empower someone today, call the IMF and find out how you can help!
I am asking you to give some of your time to changing someone's life! You
have the power to make a positive impact not only on one person, but
Thank you!
on an entire family.
Susie Novis
INTERNATIONAL MYELOMA FOUNDATION
4THANNUAL
Benefiting the PETER BOYLE MEMORIAL FUND
Hosted by
RAY ROMANO
Featuring
Dana Carvey, Susie Essman, Jeff Garlin, Dr. Ken Jeong,
Carlos Mencia, Doris Roberts, Fred Willard
Presenting
Sponsor
SATURDAY, NOVEMBER 13, 2010
THE WILSHIRE EBELL · Los Angeles
ReseRvations RequiRed
Visitusatcomedy.myeloma.orgorfol owusonfacebook.com/myelomaor@IMFComedyforprogramupdates.
Al performers subject to availability.
800-452-CURE(2873)
3
News & Notes
The content for the News & Notes section of Myeloma Today is drawn from a long list of publications
based on inquiries received by the IMF Hotline and the interests expressed by our readers.
To submit your inquiries or suggestions, please email MKazakova@myeloma.org.
Obesity and risk of MGUS
obtain a comprehensive genomic profile of presenting myeloma cases, the
Obesity has been associated with an increased risk of multiple myeloma
investigators performed high-resolution single nucleotide polymorphism
among African-Americans, although it is not known whether this increased
(SNP) mapping array analysis and examined deoxyribonucleic acid (DNA)
risk is related to socio-economic status, genetic susceptibility, or both. The
alterations in order to define the regions in which relevant genes of inter-
association of obesity with monoclonal gammopathy of undetermined
est can be found. It was discovered that the most frequent chromosomal
significance (MGUS) is unknown. Doctors at the Mayo Clinic investigated
deletions relevant to myeloma are located at 1p (30%), 6q (33%), 8p
a potential association between obesity and race and MGUS by screening
(25%), 12p (15%), 13q (59%), 14q (39%), 16q (35%), 17p (7%), 20 (12%),
1,000 African-American and 996 Caucasian women between the ages of
and 22 (18%). In addition, based on data from fluorescent in situ hybrid-
40 and 79 years, of similar socio-economic status. A total of 39 (3.9%)
ization (FISH) and other analyses, genes of prognostic importance were
African-American women and 21 (2.1%) Caucasian women had MGUS.
found to be located at 1p, 1q, and 17p. The researchers also identified
Obesity, African-American race, and increasing age were independently
deleted genes that have functions relevant to myeloma biology.
associated, on multivariate analysis, with an excess risk of MGUS. The
Arterial thrombosis in young myeloma patients
findings support the hypothesis that obesity is linked to the development
The results of a prospective cohort study by researchers in the Netherlands
of MGUS. The 2-fold excess of MGUS among African-Americans compared
show a high incidence of arterial thrombosis in young patients treated for
to Caucasians of similar socio-economic status supports the investigators'
myeloma. This study evaluated the risk of arterial thrombosis in 195 newly
hypothesis for susceptibility genes in MGUS.
diagnosed patients, aged 18 to 65 years. All patients were treated with thee
MGUS and risk of skeletal fractures
cycles of VAD (vincristine, doxorubicin, dexamethasone) or TAD (thalido-
A group of researchers from Sweden and the United States conducted a
mide, doxorubicin, dexamethasone) or PAD (bortezomib, doxorubicin,
study of the risk of skeletal fractures for patients with monoclonal gam-
dexamethasone) followed by high-dose melphalan and autologous stem
mopathy of undetermined significance (MGUS). Using population-based
cell transplantation (ASCT). During a total of 522 patient-years, 11 of the
data from Sweden, the investigators assessed the risks of fractures in 5,326
195 patients (5.6%) developed arterial thrombosis. The highest incidence
MGUS patients diagnosed between 1958 and 2006, and compared these
was seen during induction chemotherapy prior to ASCT. Hypertension
patients to matched controls. It was found that individuals with MGUS
and smoking were significantly associated with contributing to the risk
had an increased risk of fracture at five and 10 years. The risk was signifi-
of arterial thrombosis. The researchers concluded that myeloma patients
cantly higher for skull, vertebra, pelvis, sternum, and rib fractures when
have an increased risk for arterial thrombotic events during and after
compared to fractures of arms and legs. Risk for fractures did not differ
induction chemotherapy. mt
by M-protein concentration at diagnosis. MGUS patients with fractures
had no excess risk of progressing to multiple myeloma or Waldenström's
Help the IMF learn more about myeloma patients
macroglobulinemia when compared to individuals in the control group.
Whether you are a myeloma patient or a caregiver who can provide
information on behalf of a patient, you can help the IMF by
Myeloma-associated chromosomal abnormalities
participating in our latest Myeloma Patient Survey. No personal
Researchers in the United Kingdom, including IMF Scientific Advisors
identifying information is gathered as part of the survey. All responses
Gareth Morgan and Faith Davies, are studying myeloma-associated
are anonymous. Please visit at http://survey.myeloma.org.
chromosomal copy number abnormalities and their prognostic value. To
What do you get at an imf patient & famiLy seminar?
Education · Access to Experts · Camaraderie
topics Covered
· What's New in Myeloma? · Ask-the-Expert
· Managing Side Effects · How to be a Better Patient
· Frontline Therapy · Transplant · Bone Disease
· Maintenance Therapy · Relapse · Novel Therapies
Regional Community Workshops (RCW)
Go to our website www.myeloma.org
If you cannot get to a P&F Seminar, consider attending a Regional
and click on the "meetings & events"tab
Community Workshop. These half-day meetings provide Education,
Access to Experts, and Camaraderie. Registration is free but you must
for more details, the most up-to-date faculty,
register. It's a great way to learn from myeloma experts, as well as
hotels and registration information.
share experiences and gain strength from others in the IMF family.
Find more details about the next RCW near you at our website.
4
www.myeloma.org
Scientific & Clinical
imWg summit Lays the groundWork for a course toWard a cure
Data builds support for continuous myeloma treatment to extend remissions
The IMF held the inaugural Myeloma myeloma treatment and care. The investigators represented more than
Summit, a first-of-its-kind meeting of
20 countries and over 30 institutions. On the evening of June 7, IMF
the International Myeloma Working Group
President Susie Novis welcomed the participants to the Myeloma Summit,
(IMWG). The Myeloma Summit took place on
IMF Chairman and medical director Dr. Brian G.M. Durie summarized
June 79 in Barcelona, Spain. The Myeloma
the goals and expectations for the meeting, and Dr. S. Vincent Rajkumar
Summit convened between two of the year's
provided an overview of the current status of myeloma treatment and
largest cancer conferences, the American
highlighted key questions in the search for chronic disease control, as well
Society of Clinical Oncologists (ASCO) in Chicago and the European
as potential strategies to ultimately achieve a cure.
Hematology Association (EHA) in Barcelona.
June 8 began with concise summaries of translational research (which
The IMWG consists of 130 myeloma scientific advisors from around the
"translates" scientific discoveries into practical clinical applications). This
globe, including all the major myeloma research centers and clinical trial
set the stage for integration of available research into correlative studies
groups. The IMWG has been gathering annually at the exposition of the
for planned clinical trials, as well as enhancing the search for targets for
American Society of Hematology (ASH) and for additional roundtable and
new anti-myeloma drugs. The main part of the meeting then began with
consensus meetings as necessary. As of now, over 30 publications have
overviews of the key myeloma issues for 2010. Each topic presented an
been generated from the collaborative efforts of the IMWG members,
opportunity for input from all participants. After general agreement was
including numerous myeloma guidelines and consensus statements, as
reached, investigators separated into five smaller discussion groups to
well as genetic publications linked to the IMF's Bank on a Cure® research
devise plans and recommendations to address each key issue. The out-
initiative. This year, it was decided to expand and enhance the IMWG
comes were many and diverse. However, it is difficult to summarize all the
activities by holding a true "working" summit to identify and implement
details. In brief, the main recommendations were:
new strategies in the search for better myeloma therapies on the road to
Group 1: Early high-risk smoldering myeloma
finding a cure. The IMWG Myeloma Summit mission is to identify, sup-
Lead: Dr. Vincent Rajkumar
port, and implement the most promising research to prevent onset of
Recommendations: identify best risk factors; research for new/better
active disease, improve treatment, and find a cure for myeloma.
factors; use time-to-progression (TTP) as target group; plan and imple-
ment new trials, and much more.
The IMWG Myeloma Summit mission is to identify,
support, and implement the most promising research
Group 2: Sequential versus curative strategies
Lead: Dr. Antonio Palumbo
to prevent onset of active disease,
Recommendations: phase III trials required to provide answers; incor-
improve treatment, and find a cure for myeloma.
porate risk stratification; use progressive free survival as initial end-
point; develop recommendations to reduce bortezomib (VELCADE®)
Given the wide range of experience within the IMWG, the Myeloma
neuropathy; defer use of gene expression profiling (GEP) for risk clas-
Summit discussions were intended to lay the groundwork to move beyond
sification in the clinic, and much more.
long-term remissions and begin charting a roadmap for an actual cure.
Group 3: Role of autologous stem cell transplant (ASCT)
However, the availability of a growing number of myeloma treatment
and consolidation
options raises questions about when to use which treatments for which
Lead: Dr. Philippe Moreau
patients.
Recommendations: further randomized trials required; new condition-
The first Myeloma Summit brought together nearly 70 of the world's lead-
ing regimens should be explored; age > 65 and renal dysfunction do
ing experts in myeloma and related blood cancers charting the future of
not exclude ASCT, and much more.
ConTinues on Page 9
IMWG attendees included: S. Vincent Rajkumar, Niels Abildgaard, Rafat Abonour, Hervé Avet-Loiseau, Michel Attal, Ashraf Badros, Bart Barlogie, Meral Beksaç, Dina Ben-Yehuda,
P. Leif Bergsagel, Jenny Bird, Joan Bladé, Mario Boccadoro, Wen-ming Chen, Marta Chesi, James Chim, Wee-Joo Chng, Ray Comenzo, John Crowley, Faith Davies, Cármino De Souza,
Matthew Drake, Brian GM Durie, Hermann Einsele, Dorotea Fantl, Gösta Garhton, Christina Gasparetto, Hartmut Goldschmidt, Roman Hájek, Jean-Luc Harousseau, Jian Hou,
Vania Hungria, Hans Johnsen, Artur Jurczyszyn, Jonathan Kaufman, Shaji Kumar, Robert Kyle, Ola Landgren, Jae Hoon Lee, Xavier LeLeu, Suzanne Lentzsch, Sagar Lonial,
Heinz Ludwig, Angelo Maiolino, María Victoria Mateos, Ulf-Henrik Mellqvist, GiamPaolo Merlini, Philippe Moreau, Amara Nouel, Antonio Palumbo, Angelina Rodríguez Morales,
Laura Rosińol, Jesús San Miguel, Sabina Sevcikova, Orhan Sezer, Jatin Shah, John Shaughnessy, Chaim Shustik, David Siegel, Pieter Sonneveld, Edward Stadtmauer, Keith Stewart,
Evangelos Terpos, Ingemar Turesson, Ben Van Camp, Isabelle Vande Broek, David Vesole, and Jan Westin.
800-452-CURE(2873)
5
Scientific & Clinical
2010 asco key myeLoma presentations
Myeloma Today in conversation with Dr. Brian G.M. Durie
Please share with our readers a brief recap of
The researchers looked at more than 500 patients on
the general themes in myeloma and the key
a combination therapy of bortezomib, melphalan,
presentations at the 2010 ASCO meeting.
prednisone, and thalidomide followed by maintenance
The 2010 annual meeting of the American Society of
with bortezomib and thalidomide. The four-drug ther-
Clinical Oncologists (ASCO) was held June 48 in
apy followed by maintenance demonstrated improved
Chicago, IL. ASCO is one of two major annual meet-
responses compared to patients on a three-drug thera-
ings that take place in the US and involve key topics
py without maintenance. The data had been presented
in myeloma. The second such meeting is held by the
before, but the two significant aspects of the ASCO pre-
American Society of Hematology (ASH) in December
sentation looked at the possibility of switching to one
of each year. The format of these two meetings is fairly
day a week of bortezomib as induction, with reduced
similar. There are educational sessions, overviews
side effects but without reduced efficacy.
from leading experts in the field, oral sessions, and a
Another significant study demonstrating that reduced-
large number of poster sessions. In addition, there are
dosage bortezomib-based regimens may lessen toxic-
many abstracts available only in publication form. In
ity without compromising efficacy showed the benefit
recent years, the general discussions in myeloma have
of low-dose bortezomib administered once every two
followed a pattern:
weeks, combined with low-dose daily thalidomide as
1. New data on the three approved novel anti-myelo-
maintenance.
ma agents (thalidomide, bortezomib, and lenalido-
Brian G.M. Durie, MD
There were a number of other promising bortezomib
mide) that have made a significant difference in the
Aptium Oncology
trials, including those that combine bortezomib with
field in the last 510 years.
Cedars-Sinai
lenalidomide.
2. New data on the two most promising drugs in
Comprehensive Cancer Center
Los Angeles, CA
What other trials did you find to be of most
development (carfilzomib and pomalidomide).
interest?
3. Drugs in early development (elotuzumab, vorinostat, and others).
The two multi-center trials of approximately 600 patients, each of which
4. Advances in combination therapies.
showed a decreased risk of disease progression in more than half of the
What were some of the studies presented this year at ASCO that
patients on a lenalidomide-based maintenance therapy following an ASCT,
involved lenalidomide and/or bortezomib?
are very significant. In fact, this development was highlighted by ASCO as
The role of lenalidomide as maintenance is of much interest for discus-
one of the most important in 2010.
sion, and two significant randomized trials presented at ASCO garnered
The Italian study directly comparing a lenalidomide-based regimen to
a lot of attention. One study is from the IFM, which is the French myelo-
ASCT was interesting. The results of drug therapy were shown to be com-
ma study group, and the other study is from the Cancer And Leukemia
parable to ASCT but without the risk, recovery time, and debilitating side
Group B (CALGB) in the US. Both of these studies looked at the role of
effects.
lenalidomide (REVLIMID®) in the post-transplant setting. Large numbers
Is there a general shift of perspective among myeloma clinicians?
of myeloma patients who had gone through induction therapy followed by
a single autologous stem cell transplant (ASCT), were randomized 6 to 12
Continuous therapy is becoming the new paradigm of treatment in myelo-
months after transplant into two groups. One group took 10 to 15 mg of
ma. Traditionally, doctors have treated cancer until a desired response is
lenalidomide as maintenance; the other received a placebo.
reached and then treatment stops. The novel anti-myeloma therapies can
be tolerated long-term and offer physicians and patients the potential to
The IFM study looked at 614 patients. At three years, 68% of the patients
modulate the immune system to maintain remissions. Myeloma doctors
who received lenalidomide were still in remission compared to 35% in the
have been leaning toward continuing treatment as a way to prevent or at
placebo arm. With almost double the number of patients in the placebo
least delay disease relapse. The ASCO data may tip the balance in favor of
arm, the statistical difference is highly significant. Obviously, although it
that approach.
is too early to draw a conclusion, we are hopeful that the patients who
achieve prolonged remissions will also have increased overall survival
What about the next generation of anti-myeloma agents?
(OS).
The two new drugs in development that have emerged as being closest
The patients in the CALGB study had received a broad variety of induction
to possible approval for myeloma are pomalidomide (a third-generation
therapies but were standardized by entering the study after their ASCT. Of
immunomodulator in the same class as thalidomide and lenalidomide)
the 210 patients randomized to receive lenalidomide maintenance, only
and carfilzomib (a second-generation proteasome inhibitor in the same
29 patients relapsed. In the placebo arm, 58 of 208 patients relapsed. Both
class as bortezomib). At ASCO, the "next generation" data of significance
the progression-free survival (PFS) and the time-to-progression (TTP)
to patients include updates on both of these drugs. Also of importance
were better in the lenalidomide arm of the study.
were presentations on drugs in early development, such as epigenetic
drugs that work on the function of genes, as well as drugs that target
Were there significant studies of bortezomib presented at ASCO?
unique features of myeloma cells.
There were close to 50 abstracts at ASCO that presented data on combina-
Any closing comments?
tion studies with bortezomib (VELCADE®).
I believe that the clinical and scientific progress being made in myeloma
One study of particular interest was presented by investigators from Italy.
will serve as a roadmap for transforming the treatment of a wide range of
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Scientific & Clinical
the roLe of vorinostat in reLapsed/refractory muLtipLe myeLoma
Myeloma Today in conversation with Prof. Meletios A. Dimopoulos
How do you define "relapsed" and "refractory"
several malignancies. In 2006, vorinostat was approved
multiple myeloma?
in the United States for the treatment of patients with
I define relapse as the presence of clinically active
cutaneous T-cell lymphoma who have progressive,
disease in patients who have received one or more
persistent, or recurrent disease on or following two
prior therapies. Refractory multiple myeloma can
systemic therapies. The safety and tolerability of vori-
be defined as either progressive disease (PD) or
nostat has been well-documented both in patients with
stable disease (SD) while on therapy, or PD within 3
hematologic malignancies and those with solid tumors.
months of the last dose of prior therapy.
Preliminary studies of vorinostat in patients with
relapsed/refractory myeloma did not show significant
What are the challenges of treating relapsed or
single-agent activity, but there was a significant in vitro
refractory myeloma?
rationale to combine vorinostat with either bortezomib
Patients with relapsed/refractory myeloma can be
or lenalidomide.
categorized as following: patients who are refractory
What was that rationale?
to frontline therapies, patients who have relapsed
but who are not refractory to treatment, and
Preclinical data of vorinostat in myeloma showed that
patients who are both relapsed and refractory.
it has antiproliferative/proapoptotic activity against
Newly-diagnosed myeloma is usual y responsive
human myeloma cells, overcomes the protective effect
to initial treatment. However, most patients with
of bone marrow stromal cells on myeloma cells, and
this disease eventually relapse or become not read-
enhances the response of myeloma cells to other anti-
Meletios A. Dimopoulos, MD
ily responsive to currently available anti-myeloma
myeloma compounds. The data from the preclinical
Department of Clinical Therapeutics
agents. This is due in part to the evolving biology of
studies provided the "proof of concept" that led to the
University of Athens School of Medicine
myeloma and/or the development of drug-resistance
Alexandra Hospital
development of clinical trials to further explore the
within the cancer cells.
Athens, Greece
activity of this compound in myeloma.
What are the currently-available treatment options for relapsed/
VANTAGE 074, a phase I multicenter, open-label study
refractory disease?
of vorinostat, lenalidomide, and dexamethasone for relapsed/refractory
myeloma aimed to determine the maximum tolerated dose (MTD) for that
Currently, three novel agents are approved in most countries for the
three-drug combination regimen. Most study patients received prior ther-
treatment of myeloma as frontline therapy and/or in the relapsed/refrac-
apy with bortezomib, thalidomide, and/or lenalidomide. Based on April
tory setting: thalidomide (THALOMID®), lenalidomide (REVLIMID®),
2010 preliminary data, 26 of 30 patients evaluable for efficacy (86.7%)
and bortezomib (VELCADE®). These novel agents are used in frontline
had clinical benefit: complete response (CR) + partial response (PR) +
therapy and can provide clinical benefit in relapsed/refractory disease.
minimal response (MR) + stable disease (SD) on treatment. In addi-
But not all relapsed/refractory patients will respond to currently approved
tion, data showed that MTD has not been reached, with no dose-limiting
drugs, and the responses can be limited in duration. For patients with
toxicities (DLT) prohibiting dose escalation. This suggests that vorinostat
relapsed myeloma who are refractory to these agents, there is an urgent
combined with lenalidomide and dexamethasone may be an effective and
need to develop targeted agents that provide durable disease control and
generally well-tolerated oral regimen for patients with relapsed/relapsed
symptomatic relief.
myeloma. Further data collection and review are ongoing, and a phase II
Please give us a brief overview of the targeted agents that are
study is planned.
currently under investigation for myeloma.
Indeed, the phase I and II clinical studies of vorinostat in myeloma
The progress being made in the treatment of relapsed/refractory myeloma
showed interesting activity indicating that there was clinical synergy
is encouraging. Several new agents from a range of therapeutic classes and
between vorinostat and bortezomib, as well as vorinostat and lenalido-
with varied rationales for use in myeloma are showing potential to provide
mide. Investigation of vorinostat plus lenalidomide has been presented
improvements in response and survival in the relapsed/refractory setting.
at recent annual meeting of the American Society of Hematology (ASH),
Agents in development for the treatment of bortezomib- or lenalido-
the American Society of Clinical Oncology (ASCO), and the European
mide-resistant myeloma include pomalidomide, carfilzomib, perifosine,
Hematology Association (EHA). Vorinostat was shown to have activity in
elotuzumab, and several histone deacetylase (HDAC) inhibitors (e.g.,
heavily pretreated myeloma patients and in those who are refractory to
panobinostat, romidepsin, and vorinostat). Completion of the numerous
bortezomib and lenalidomide.
ongoing clinical investigations should determine which, if any, of these
newly emerging therapies are viable treatment options for patients with
What are the significant ongoing clinical trials?
relapsed/refractory myeloma.
At present, there are two major clinical trials of vorinostat. One of these
You have been involved with studies of vorinostat for relapsed/
trials VANTAGE 095 is a large phase IIb international open-label
refractory myeloma. Please tell us about this compound and its
single-arm study designed to assess efficacy and safety of treatment with
development history.
vorinostat plus bortezomib in patients who are refractory to bortezomib
and 1 immunomodulatory drug (IMiD) regimens and are ineligible for
HDAC inhibition may play a critical role in controlling tumor growth
other approved regimens. Such patients are known to have very poor
and increasing survival. Vorinostat (suberoylanilide hydroxamic acid)
outcomes, with a median survival of 6 months or less, so this trial is very
is an oral HDAC inhibitor that has been developed for the treatment of
ConTinues on Page 9
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Scientific & Clinical
the roLe of carfiLzomib in myeLoma
Myeloma Today in conversation with Dr. David S. Siegel
You are working with carfilzomib, a second-
presented at several major meetings, including
generation proteasome inhibitor. How does this
the American Society of Hematology (ASH), the
compound differ from bortezomib?
American Society of Clinical Oncology (ASCO),
Proteasome inhibition affects expression of a number
and the European Hematology Association (EHA).
of proteins involved in the cell cycle, causing apoptosis
Carfilzomib has been shown to have excel ent
in myeloma cells. The first proteasome inhibitor that
activity both in heavily pretreated patients and in
became commercially available for use in myeloma
those who were not. It is active in patients who
is bortezomib (VELCADE®), which is a boron salt.
have been previously treated with bortezomib and,
Bortezomib is a "competitive" inhibitor of the protea-
more importantly, carfilzomib has been shown to
some. This means that while bortezomib is around, the
be active in patients who are bortezomib-resistant.
proteasome is inhibited, but as soon as the levels of bort-
There are now two ongoing phase II clinical trials
ezomib are reduced, the proteasome resumes its activity.
investigating the efficacy, safety, and tolerability
In contrast to bortezomib, which has an effect on myelo-
of carfilzomib as single-agent therapy in myeloma
ma cells that is reversible, carfilzomib targets the same
patients with relapsed/refractory disease. One ongo-
proteasomes irreversibly. We call carfilzomib a "non-
ing phase II clinical trial is evaluating relapsed/
competitive" proteasome inhibitor. Carfilzomib, which is
refractory patients who have received prior treat-
an epoxyketone, binds to and destroys the proteasome
ment with bortezomib, and either thalidomide
permanently. So while both bortezomib and carfilzomib
or lenalidomide, and are refractory to their last
hit the same target, they hit it in very different ways.
David S. Siegel, MD, PhD
treatment. This study is open-label, single-arm, and
Chief, Myeloma Division
non-randomized.
In the myeloma setting, how is the permanent
John Theuer Cancer Center
impact of carfilzomib preferable to the temporary
Hackensack, NJ
The second ongoing phase II clinical trial is an
action of bortezomib?
open-label, single-arm, non-randomized study test-
Proteasomes are essential to cells, so inhibiting proteasomes is a potential-
ing the activity and safety of carfilzomib in relapsed/refractory patients
ly dangerous thing. While carfilzomib targets the proteasome selectively,
who had 1-3 prior therapies and relapsed to the most recently-received
we certainly did not know until it was tested that carfilzomib would turn
therapy. There are two patient populations in this study: patients with
out to be the more effective proteasome inhibitor. But the data gathered
relapsed and/or refractory myeloma who had not received prior bortezo-
from numerous investigations of carfilzomib is showing that it is at least
mib therapy and patients with relapsed and/or refractory disease following
as effective against myeloma as bortezomib, if not more effective, and it
treatment with bortezomib.
has a better toxicity profile.
Phase III clinical trials of carfilzomib will be opening at the end of 2010.
Part of the rationale for developing a new drug is to improve efficacy and/
One phase III international randomized clinical trial has been initiated to
or tolerability, as well as to address potential drug-resistance to the first-
evaluate the safety and efficacy of carfilzomib in combination therapy with
generation drug. In other words, in patients who have become resistant
lenalidomide and low-dose dexamethasone compared to lenalidomide
to bortezomib, the use of a new proteasome inhibitor such as carfilzomib
and low-dose dexamethasone alone in patients with relapsed myeloma.
might overcome the resistance to bortezomib.
I'd also like to mention that there are additional ongoing clinical trials
What have the studies shown about carfilzomib?
with carfilzomib using a different route of administration. It seems that
administering carfilzomib via infusion allows for higher doses of the
Carfilzomib has generated very positive data in several early-phase studies.
compound to be used and we are hopeful that this will show even better
The phase I clinical trials of carfilzomib showed that it was well-tolerated.
responses in patients.
In addition, the low rates of peripheral neuropathy (PN), a side effect of
several myeloma therapies, make carfilzomib very much different from
What are the prospects for this drug to become available to
bortezomib and the other boronated proteasome inhibitors.
myeloma patients outside the clinical trial setting?
In a phase I study of 19 patients who had relapsed following or became
It is anticipated that the clinical trial data will support a new drug
refractory to previous therapies, treatment with carfilzomib resulted in an
application (NDA) filing in the United Stated by the end of 2010, and
overall response rate (ORR) of approximately 17%, indicating that single-
we are certainly hoping for a fast-track approval by the Food and Drug
agent carfilzomib is active in relapsed/refractory myeloma.
Administration (FDA).
An ongoing phase Ib multicenter, open-label, single-arm, non-randomized
Is there anything you'd like to add in closing?
dose escalation clinical trial of carfilzomib plus lenalidomide and low-dose
The carfilzomib clinical trials are continuing to mature and the data is
dexamethasone in relapsed/refractory myeloma is studying four dose
continuing to be presented at the major hematology meetings. The data
levels in order to evaluate safety and define the maximum tolerated dose
from all of the trials seem to confirm the initial presentation that carfilzo-
(MTD) of this three-drug combination in patients who had failed 1-3 prior
mib is well-tolerated by patients and that it seems to have a high degree
therapies, including prior treatment with lenalidomide or bortezomib.
of activity against myeloma. It is also important to add that the patients
What can you share with us about phase II and III clinical trials of
who respond to carfilzomib achieve responses that are quite durable.
carfilzomib?
Carfilzomib is active in patients who are refractory to bortezomib and
it seems to cause little to no PN, which is the main limiting factor in the
The data from phase II trials of carfilzomib in myeloma have been
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Scientific & Clinical
IMWG SUMMIT -- continued from page 5
Group 4: Maintenance therapy
non-secretory myeloma. It was also proposed to record, in a standard-
Lead: Dr. Heinz Ludwig
ized fashion, other diseases and illnesses (so called "co-morbidities") in
Recommendations: drug orphans guideline manuscript is planned;
myeloma patients.
further studies required.
By the end of the Myeloma Summit on June 9, there was great excitement
Group 5: New drugs
Lead: Dr. Sagar Lonial
about all that had been presented during the meeting, as well as the plans
Recommendations: new drug development is crucial; testing in relapse/
made for the future. One gratifying sentiment voiced by many Myeloma
refractory disease and other settings; discuss and define ideal from-lab-
Summit participants was that this unique meeting had been the best they
to-clinic sequence; key current agents identified.
had ever attended. By popular demand, the timing and location of the
next Myeloma Summit is already being explored for 2011. The outlook
In addition to these broad recommendations, specific projects were
is very promising for ongoing, active, and collaborative involvement of
discussed in follow up of ongoing or recently planned IMWG consensus
IMWG members in key projects which will undoubtedly lead to better
and database projects. A few of the newer projects include possible collec-
myeloma disease control and, ultimately, a cure. mt
tive analyses of GEP data, updating of both CRAB (C = elevated Calcium,
R = Renal failure, A = Anemia, B = Bone lesions) and IMWG response
Editor's Note: To read the consensus statements and published papers
criteria, studies of plasma cell leukemia, extra-medullar disease, and
produced by the IMWG, please visit the IMF website and click on the
"research" tab
DUrIE / 2010 ASCO -- continued from page 6
cancers. We are seeing myeloma treatments work in lymphomas, leuke-
ence could change the way they are treated. Overall, the data favor fewer
mias, and even solid tumors. In fact, there is much promise in the early
stem cell transplants and increased use of maintenance therapy continu-
data from studies evaluating lenalidomide in prostate cancer, as well as
ing therapy even in patients who have achieved a complete response (CR).
second-generation proteasome inhibitors (carfilzomib and an oral drug
The progress and positive news presented at ASCO and other medical
from the makers of VELCADE) in several different malignancies.
meetings are truly encouraging. While we must continue to work toward
As for myeloma patients, the presentations made at the 2010 ASCO confer-
a cure, it is clear that many myeloma patients are already living longer,
better lives. mt
DIMOPOULOS / vOrINOSTAT -- continued from page 7
important in attempting to address a currently unmet need.
a heavily pretreated patient population. Of course, we have to wait until
The second major ongoing clinical trial of vorinostat is VANTAGE 088,
this study is fully accrued. But, hopefully, we will continue to see induced
a phase III multi-center randomized double-blind study of vorinostat or
responses in 20-30% of participating patients who have disease which is
placebo combined with bortezomib in relapsed myeloma. The primary
otherwise refractory to all types of standard treatments. We have submit-
objective of this study is to determine the progression-free survival (PFS)
ted an abstract to ASH 2010, and it is now under review.
of vorinostat plus bortezomib, compared with placebo plus bortezomib,
What is your assessment of vorinostat so far?
in myeloma patients who had received between one and three prior treat-
I think that vorinostat is a very interesting compound. So far, the safety
ment regimens. The patients being accepted into this study must not be
of the compound is looking reasonable, and we hope that the data
refractory to bortezomib.
will also show positive efficacy. Of course, patients receiving vorinostat
Are you involved with both of the currently ongoing clinical trials?
require close follow-up, and might require dose adjustment, because
Yes, I am working on both VANTAGE 088 and VANTAGE 095 as a member
it is associated with gastro-intestinal toxicity, a sense of weakness and
of the steering committee. The VANTAGE trial is the largest clinical study
fatigue. However, the combination of vorinostat with either bortezomib or
for myeloma, enrolling 742 patients at 265 sites in 32 countries through-
lenalidomide has been shown to be generally well-tolerated.
out the world VANTAGE 088 should conclude the accrual process within
Some study patients with resistant myeloma, for whom there are no other
the next year. VANTAGE 095 is closer to completion of the patient accrual
available treatment options, are showing some response from vorinostat
process, and we should have a formal interim analysis completed by the
plus bortezomib. So VANTAGE 088 and VANTAGE 095 are both very impor-
end of this year.
tant clinical trials. We are looking forward to their completion, as there is
We do not yet have the final response data from the VANTAGE 095 study,
a reasonable hope that the results of these trials may lead to a new treat-
but the preliminary data show that vorinostat has activity in myeloma.
ment option being approved for patients with advanced myeloma. mt
This is rather interesting, especially considering that this data comes from
SIEGEL / CArFILzOMIB -- continued from page 8
administration of bortezomib. To be able to achieve a high degree of
but started asking how soon he could return to work!
response that is durable without sacrificing quality of life is very exciting.
I have worked with carfilzomib in phase I trials, am now working with
I have had wonderful experiences with patients on this drug, both in
it in phase II trials, and will hopefully be involved with the phase III
terms of toxicity and response. I had an experience with one patient, who
trials of carfilzomib in as well. We have had a tremendous amount of
was in hospice care at another major myeloma institution and came to us
experience with carfilzomib in myeloma and I can tell you that it is a
for the phase II trial of carfilzomib, who not only responded to treatment
wonderful drug. mt
800-452-CURE(2873)
9
Supportive Care
sexuaL dysfunction and its impact on muLtipLe myeLoma
Myeloma Today in conversation with Tiffany Richards
Overthepastdecade,advancesinanti-myeloma
illnesses (medications, chemotherapy, or radiation)
therapy have led to better overall survival for
or their associated complications, may worsen symp-
patients with multiple myeloma. New treatments
toms. The effects of disease on sexual dysfunction
provide hope for extended disease-free periods and
vary in the degree and the type of dysfunction.
improved outcomes for patients. As more people
In patients with myeloma, treatment may precipitate
are living longer with myeloma, members of the
diseases such as diabetes, hypertension, and anemia.
IMF Nurse Leadership Board (NLB) are addressing
Additionally, myeloma may impact renal function,
the evolving needs of myeloma survivors. Patient
mobility, and pain due to bone disease or neuropathy.
survivorship care planning allows for optimal man-
Patients receiving treatment may experience disrup-
agement of emergent late-term effects and improved
tions in sexual response as a result of fatigue, weak-
quality of life. The NLB Survivorship Care Plan, which
ness, pain, and alterations in body image. Additionally,
is currently being prepared for publication, examines
patients with compression fractures may experience
five specific aspects of long-term care for the benefit of
pain and diminished mobility, inhibiting sexual func-
patients and the nurses who work with them. The five
tion. Chronic pain requiring long-term opiate use
areas are: Health Maintenance, Sexuality and Sexual
affects erectile function, hormonal levels, and libido.
Dysfunction, Renal Complications (see Spring 2010
Myeloma Today), Bone Disease & Bone Health (see
Cardiovascular disease (hypertension, atherosclerosis,
Tiffany richards, MS, ANP-BC, AOCNP
Spring 2010 Myeloma Today), and Functional Mobility
vascular disease, cerebral vascular events) has sys-
MD Anderson Cancer Center
and Safety (see Summer 2010 Myeloma Today).
Houston, TX
temic effects including sexual dysfunction. Men with
Tiffany Richards, the leader of the sexuality and
erectile dysfunction (ED) have an increased incidence
sexual dysfunction task force, spoke with Myeloma Today about
of cardiovascular events. The risk of cardiovascular events among women
the work of her team.
who have cardiovascular disease is not known. Myeloma patients receiving
treatment with steroids are at increased risk of developing hypertension
What is the definition of sexual dysfunction?
and require close monitoring of blood pressure during treatment.
The World Health Organization defines sexuality as a "central aspect of
being human throughout life and encompasses sex, gender identities and
Radiation to the pelvis may cause delayed arousal and orgasm through
roles, sexual orientation, eroticism, pleasure, intimacy, and reproduc-
damage of the pelvic vascularity and nerves. Women may develop
tion." Sexuality is influenced by many interactions of biological, psycho-
vaginal stenosis and fibrosis leading to dyspareunia and painful pelvic
logical, social, economic, political, cultural, ethical, legal, historical and
examinations.
religious and spiritual factors.
The use of thalidomide/lenalidomide in the treatment of women with
Sexual dysfunction occurs when a disruption of the sexual response cycle
myeloma may disrupt sexual function due to the requirements of birth
occurs as a result of physical illness or psychological factors rather than
control measures. Oral contraceptives may cause decreased libido, and
part of the normal aging process. Sexual dysfunction can be described as
may affect sexual function by decreased testosterone levels.
one of four main categories: sexual desire disorder (decreased libido),
Body image, depression, concerns about the future, abandonment issues,
sexual arousal disorder, orgasm disorder, and sexual pain disorders.
and history of abuse may have a negative impact on sexual function. A
study of cancer patients found that the effects of treatment impaired men-
What are the causes of sexual dysfunction in illnesses in general
tal well-being, thus affecting body image. Body image-related side effects
and myeloma in particular?
were reported as the most severe chemotherapy side effect. In myeloma,
Review of the literature regarding sexual function in cancer patients is lim-
treatments produce both temporary and permanent changes, potentially
ited primarily to patients diagnosed with prostate, breast, or gynecological
affecting body image and thereby influencing sexuality. Dependency on
cancers. There is little research regarding sexual dysfunction in patients
caregivers may have an impact on psychological well-being, particularly if
with multiple myeloma, so the information related to the assessment and
they require assistance that minimizes their privacy.
evaluation of sexual dysfunction is gleaned from other malignancies and
diseases. My NLB task force is working on promoting dialogue and assess-
What is the impact of myeloma and its treatments on sexual
ment practices amongst myeloma patients.
dysfunction?
Patients undergoing treatment for myeloma may experience an exacerba-
Disruption of cancer patients' normal sexual functioning and
tion of pre-existing disorders or develop new disorders as a consequence
fertility has been documented in those receiving traditional chemo-
of treatment. Physical disorders that may have an impact on sexual func-
therapy. Additionally, high-dose therapy with melphalan followed by
tioning include endocrine abnormalities, cardiovascular disease, pelvic
autologous stem cell transplantation precipitates a chemically-induced
disease, cancer, and renal insuffiency. In addition, treatment of these
ConTinues on Page 16
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Supportive Care
imf hotLine coordinators ansWer your Questions
The IMF Hotline 800-452-CURE (2873) consistently provides cal ers with the best information about myeloma
in a caring and compassionate manner. The Hotline is staffed by Nancy Baxter, Debbie Birns, Paul Hewit ,
and Missy Klepetar. The phone lines are open Monday through Friday, 9 a.m. to 4 p.m. (Pacific Time).
To submit your question online, please email TheIMF@myeloma.org
I am receiving VELCADE® as part
of Salamanca, Spain, concluded that low
of my treatment regimen. Is there a
rates of PN were observed after a modi-
consensus among myeloma doctors
fied bortezomib regimen that consisted
on VELCADE dosing?
of one 6-week cycle administered twice
Bortezomib (VELCADE®) is an effective
a week, followed by subsequent cycles
and widely used treatment for mul-
in which bortezomib was administered
tiple myeloma. It can be given alone,
in a weekly schedule (four weekly bort-
in combination with dexamethasone,
ezomib doses at 1.3 mg/m2 followed by
or in a variety of three- and four-drug
one week of rest).
combinations. Because of bortezomib's
Based on these trial results and the
effectiveness, it is essential to ensure
combined clinical experience of the
that patients are able to tolerate it well
IMWG experts, the IMWG concluded
and not discontinue receiving bortezomib infusions because of side effects.
that weekly bortezomib dosing and earlier detection of PN are therapeutic
Peripheral neuropathy (PN) which causes numbness, tingling, and/
options to minimize the risk of neuropathy. Specific guidelines for deter-
or sometimes pain in the hands, arms, feet, and/or legs is a common
mining bortezomib dose, which will soon be published in an IMWG paper,
problem among myeloma patients. Myeloma itself can cause PN, as can
are the following:
diabetes mellitus. Two of the most common novel therapies for myeloma,
· Patients who have no PN can be treated with bortezomib in the traditional
thalidomide (Thalomid®) and bortezomib, can also cause PN or worsen
twice weekly schedule.
pre-existing PN. Because the goal of any treatment for myeloma is to attack
the disease while preserving the patient's quality of life, it is important to be
· Patients with low-level neuropathy (defined as "Grade 1" using the
aware of this potential problem and to nip it in the bud before it becomes
National Cancer Institute's common toxicity criteria: numbness, weak-
a debilitating and permanent condition.
ness, and/or loss of reflexes, but without any pain or loss of function in
performing the activities of daily living) should be carefully evaluated by
At a meeting of the International Myeloma Working Group (IMWG) that
their physicians for the existence of PN risk factors and managed appro-
took place in June 2010 in Barcelona, Spain, the myeloma experts who
priately. Consideration should be given to administering bortezomib
were gathered from around the world addressed many key questions,
once weekly at a starting dose of 1.3 mg/m2.
including, "How do we minimize the risk of neuropathy?" To answer this
question, the experts examined important new clinical trial data that would
· For patients treated with bortezomib who develop Grade 1 neuropathy
enable them to draw up a guideline for bortezomib dosing with an eye to
who are experiencing pain, or those who have no pain but whose neu-
reducing the incidence of PN.
ropathy limits their ability to perform daily living activities (Grade 2),
consideration should be given to change bortezomib to a reduced dose
Clinical trials are the vehicle through which new drugs and drug combina-
of 1.3 mg/m2 once per week, as an alternative to the current package
tions are tested, and are often also the means through which new dosing
insert recommendation of reducing bortezomib dose to 1.0 mg/m2 twice
strategies are determined. Results of an Italian study group (GIMEMA)
weekly.
phase III randomized clinical trial, led by the University of Torino's Drs.
Antonio Palumbo and Mario Boccadoro, that compared VMPT (VELCADE,
· Patients treated with bortezomib who have Grade 2 neuropathy with
melphalan, prednisone, and thalidomide) followed by VT maintenance,
pain, or Grade 3, which is defined as severe pain, weakness, sensory
versus VMP followed by no maintenance, as first-line therapy in patients
alteration or numbness, and/or pain severely interfering with activities
ineligible for stem cell transplant were presented at the December 2009
of daily living, and needing bracing or assistance to walk, should not be
meeting of the American Society of Hematology (ASH) and at the June
given bortezomib until their side effects improve. When the PN improves,
2010) meeting of the American Society of Clinical Oncology (ASCO). During
consideration should be given to restarting bortezomib at 1.0 mg/m2
this trial, the study was amended to schedule bortezomib weekly (four
once per week (the current package insert recommendation includes
doses weekly at a dose of 1.3 mg/m2 followed by one week of rest) instead
restarting bortezomib at 0.7 mg/m2).
of the traditional twice weekly schedule, in order to reduce the rates of PN.
As always, we urge you to discuss this information with your hematologist/
The study investigators, having analyzed the data from the completed trial,
oncologist, and to report any and all symptoms of PN to your healthcare
noted, "Compared to twice weekly, the weekly infusion of bortezomib sig-
team AS SOON AS YOU EXPERIENCE THEM. Do not ignore any numbness,
nificantly reduced the incidence of PN without affecting outcome."
weakness, tingling, or pain you feel in your fingers, hands, arms, toes, feet,
In a phase III randomized study by the Spanish Myeloma Group (PETHEMA/
or legs. By reporting any and all symptoms as soon as possible, you enable
GEM) that compared VMP versus VTP followed by maintenance with VT or VP
your doctor to take prompt action to prevent what could become a debili-
as first-line therapy for myeloma, Dr. María Victoria Mateos of the University
tating and ongoing problem. mt
800-452-CURE(2873)
11
Special Event 2010 Robert A. Kyle Lifetime Achievement Award
honoring prof. Joan bLadé and his Work
The Award
The Eighth Annual Robert A. Kyle
In 1910, Dr. William Mayo set the standard for treat-
Lifetime Achievement Award
ment of patients at Mayo Clinic with these words:
The Recipient
"The needs of the patient are the only needs to be
considered." In 2003, the IMF bestowed the first annual
Prof. Joan Bladé
Lifetime Achievement Award to a physician whose work
Senior Consultant and Director of Myeloma Programs
against multiple myeloma reflects the dedication and
Hospital Clínic de Barcelona Barcelona, Spain
compassion inherent in Dr. Mayo's vow. The IMF chose
to name this award for Dr. Robert Kyle, whose life and
The IMF is proud to award its presti-
work give new meaning to Dr. Mayo's words.
gious Robert A. Kyle Lifetime Achievement
Award for 2010 to Professor Joan Bladé.
In his more than 40 years at Mayo Clinic, Dr. Kyle has never wavered from
Prof. Bladé graduated from the Medical
his commitment to the needs of patients with myeloma. He has devoted
School of the University of Barcelona.
his life's work to them. He has gained recognition the world over as a
In 1981, he joined the staff at the
pioneer and respected leader in the advancement of research, clinical
Hematology Department of Hospital
treatment, and education about myeloma.
Clínic de Barcelona, where is now the
When Brian Novis sought to learn more about his disease, he was look-
Senior Consultant and Director of the
ing for the finest doctor available to help him. When he heard about Dr.
Myeloma Programs. Prof. Bladé was co-
Kyle, Brian didn't know at the time that Dr. Kyle was considered to be the
founder of the PETHEMA Foundation,
"grandfather" of myeloma treatment.
and co-founder of the Spanish Myeloma Group. He chaired the group
that developed the European Group and Marrow Transplantation (EBMT)
Later, when Brian Novis and Dr. Brian Durie decided to create an inter-
response criteria, known today as the Bladé Criteria. He has published
national foundation dedicated to helping others with myeloma, Dr.
over 200 papers on both myeloma and MGUS, and he is an active member
Kyle was the first person they contacted. Dr. Kyle agreed to collaborate
of the International Myeloma Working Group (IMWG).
with the two Brians, and
became a founding member
The Ceremony
of the International Myeloma
The eighth annual Robert A.
Foundation's
Board
of
Kyle Lifetime Achievement
Directors and chairman of its
Award ceremony took place
Scientific Advisory Board, a
on June 9 in Barcelona, Spain.
position he still holds today.
The setting for the evening was
Can Travi Nou, a Catalonian
Dr. Kyle is a sought-after pre-
masia (typical farmhouse of the
senter at IMF clinical confer-
region) built in the early part of
ences and workshops, and is
Drs. Brian Durie and robert Kyle
the 17th century. For 300 years,
the most frequently request-
the farm was dedicated to agri-
ed speaker at IMF Patient & Family Seminars. Through IMF programs, Dr.
Drs. robert Kyle and Joan Bladé
culture and cattle ranching. At
Kyle has made himself accessible to thousands of myeloma patients and
the beginning of the 1920s, the masia was transformed into an exquisite
their families around the world. His guidance and encouragement are as
restaurant that still maintains a sense of Catalonian tradition and history.
important to the IMF today as when the IMF first began.
It was in this scenic
The IMF's Robert A. Kyle Lifetime Achievement Award was established to
setting that more
honor an individual whose lifetime body of work furthers the ultimate goal
than 200 friends
of finding a cure for myeloma. When Dr. Kyle was first approached about
and
colleagues
receiving the award, his response to Susie Novis was, "I'm not done yet."
gathered for the
His humility, dedication, sense of humor, and caring and compassionate
ceremony to honor
nature are among the many reasons for which the IMF named this award
Prof. Bladé and his
in his honor.
lifelong dedication
Dr. Kyle himself was the first recipient of the award in 2003. Subsequently,
and commitment
the award has been presented to Dr. Bart Barlogie (2004), Dr. Kenneth C.
to improving the
Anderson (2005), Dr. Brian G.M. Durie (2006), Prof. Heinz Ludwig (2007),
lives of myeloma
Prof. Mario Boccadoro (2008), and Prof. Jean-Luc Harousseau (2009).
patients while working tirelessly to further the ultimate goal of finding a
cure for this disease. The rain that had plagued the city all day ended just
in time for the arrival of the guests, which allowed the reception to be held
in the beautiful gardens of the masia.
12
www.myeloma.org
Special Event 2010 Robert A. Kyle Lifetime Achievement Award
In attendance were Dr. Bladé's lovely wife
Maite, their children Joan and Esther, his
Masia Can Travi Nou - Barcelona, Spain
mother, his brothers and their wives, and
other family members, as well as represen-
Maria del Carmen Creixenti, Maite Herrero,
tatives of the IMF, several past Robert A.
Drs. robert Kyle and Joan Bladé
Kyle Lifetime Achievement Award honorees,
Dr. Bladé's colleagues and staff from the Hospital Clínic de Barcelona,
and 50 international myeloma clinicians and researchers.
Lisa Paik, David Girard,
and Birgit Ludwig
Peter radovich and Homa Yaganegi
Birgit and Dr. Heinz Ludwig, Maite Herrero,
Dr. Jesús San Miguel and Dr. Laura rosińol
Dr. Jesús San Miguel presided over the event as master of ceremonies.
The evening's speakers included Susie Novis and Drs. Brian Durie, Robert
Kyle, Heinz Ludwig, and Ciril Rozman. Prof. Bladé's colleagues spoke
of his career, his
dedication, and his
Drs. Bart Barlogie (back to camera),
meticulousness.
Brian Durie, and Michel Attal
His son, Joan Bladé
Herrero, spoke of
the example he
sets for the family.
Prof. Bladé gave the
Dr. Mario Boccadoro, Tom Cavanaugh,
last speech of the
and Dr. Michel Attal
evening, a heartfelt
message to his father, and delivered it in Castilian Spanish, Catalonian,
and English. It was a very intimate experience that all in attendance were
permitted to share.
A photo montage, presented with musical accompaniment and prepared
Dr. Brian Durie and Susie Novis
by his friend and colleague Dr. Laura Rosińol, documented the key events
in Dr. Bladé's life. It was a humorous and insightful look at
The IMF would like to thank
Dr. Bladé's childhood, his studies, his career, his hobbies,
the sponsors for their support
of this prestigious event
and his family. (Did you know that Dr. Bladé is also an inter-
nationally known and respected breeder of canaries?)
Presenting Sponsor
Celgene Corporation
As the very special evening regretfully came to a close, every-
one was in agreement that this una nit molt catalana (very
Bronze Sponsors
Catalonian night) was an event to remember fondly for years
Binding Site
Genentech
to come.
Onyx Pharmaceuticals
Medtronic
Dan Navid, Susie Novis, and Dr. Meral Beksaç
800-452-CURE(2873)
13
International Affiliates
updates from around the gLobe
Breakthrough agreement
· Compiling data about the incidence and costs of myeloma in China;
signed with China
· Developing Chinese-language materials about myeloma for distribution
in print and via the Internet.
Longer-range goals of this joint effort include establishing a Myeloma
Patient Society in China and hosting a regional clinical conference on
myeloma for healthcare experts in Asia.
Daniel Navid (Senior Global Analyst, IMF) addressing
Chinese dignitaries at the signing ceremony in Beijing
Daniel Navid with Mr. Yingming Chang (vice Chairman and
Secretary General, CHPF) and Dr. Wenming Chen (member of the
On September 9, the International Myeloma Foundation (IMF) signed a
IMWG), and other dignitaries attending the signing ceremony
cooperative agreement with the Chinese Health Promotion Foundation
The agreement was signed by Dr. Shuzhong Bai, Chairman of the
(CHPF), an agency that operates under the Chinese Ministry of Health, to
CHPF, and by Daniel Navid, Senior Global Analyst for the IMF. The
promote awareness of myeloma in China and to encourage measures to
ceremony was hosted by Dr. Yingming Chang, Secretary General of the
prevent and combat the disease. This groundbreaking agreement substan-
CHPF. Also attending the ceremony were Dr. Xiaojun Huang, Chairman
tially expands the IMF's presence in Asia and will support the thousands of
of the Chinese Hematology Association and Hemotology Society of the
patients in China who have multiple myeloma. The agreement was signed
Chinese Medical Association, and Dr. Wenming Chen, a member of the
at a ceremony in Beijing.
International Myeloma Working Group (IMWG), an organization of inter-
national myeloma experts organized by the IMF.
IMF Asian Program meeting
in Singapore
The signing of the cooperative agreement for myeloma awareness and
Participants of the IMF Asian Program meeting in Singapore
prevention activities in China by Dr. Shuzhong Bai (Chairman
of the Board, CHPF) and Daniel Navid
On July 16, Dr. Wee Joo Chng, member of the IMF's International Myeloma
Working Group (IMWG), hosted an ad hoc meeting at the National
"Chinese health authorities clearly recognize the significance of myeloma
University of Singapore Hospital to discuss the IMF Asian Program.
in their country, and we are honored and gratified that they acknowl-
Leading myeloma experts in Singapore, as well as the regional representa-
edge the role the IMF can play in supporting patients, disseminating
tives of IMF partners Celgene and Johnson & Johnson, met with IMF's
information and encouraging research," said Susie Novis, President and
Senior Global Analyst, Daniel Navid, to consider priority requirements
Co-Founder of the IMF.
for IMF action in Asia. An IMF Asian program for 2011 through 2013 has
On behalf of the CHPF, Dr. Zhao Yanling, Head of International Relations
subsequently been prepared and is presently under review by additional
noted, "The mission of the CHPF is to bring together Chinese medical
experts in the region. This program is designed to include regional studies
experts to raise the health standard of the Chinese people, and we can
and conferences, intensified work in Japan, the launch of the IMF-China
think of no better partner to work with us on behalf of myeloma patients
program, and pilot projects for physician and patient support in Hong
than the IMF."
Kong, Korea, Singapore, and Thailand. mt
Initial goals of the agreement include:
Editor's Note: For more information, please contact Daniel Navid at
dnavid@myeloma.org or +41-21-825-5546
· Developing a scientific advisory committee of Chinese myeloma experts;
14
www.myeloma.org
Education & Awareness
spotLight on advocacy
By Christine Murphy
Cancer Research Receives
Senate Passes Improving Access
Boost in House and Senate
to Clinical Trials Act
LHHS Appropriations Bills
On August 5, 2010 the US Senate passed S 1674, the Improving Access
TheHouseLabor,HealthandHumanServices,
to Clinical Trials Act. Current rules regarding eligibility for Supplemental
and Education (LHHS) Appropriations
Security Income (SSI) prevent many people with rare diseases who receive
Subcommittee marked up the Fiscal Year
SSI from participating in clinical trials. The inability of SSI beneficiaries
(FY ) 2011 LHHS Appropriations bill on July
to accept research compensation for participation in a clinical trial has
15, 2010. The LHHS Appropriations bill
been shown to be a significant deterrence to research participation. The
included funding for important myeloma
Improving Access to Clinical Trials Act (S 1674/HR 2866) changes current
programs at the National Institutes of Health (NIH), the National Cancer
SSI eligibility requirements so that research compensation (up to $2,000)
Institute (NCI), and the Centers for Disease Control and Prevention
for participation in a clinical drug study for a rare disease or condition is
(CDC). In the House LHHS bill, the NIH received $32 billion (a $1 bil-
no longer considered income for determining SSI eligibility.
lion increase over FY 2010). This is the same amount included in the
Action on this bill turns to the US House of Representatives. In order
President's FY 2011 budget. The NCI was allocated $5.265 billion, $162
for this bill to become law, the House must take action before the 111th
million more than FY 2010 and the same level in the President's budget.
Congress adjourns later this year. To see if your Members of Congress sup-
On July 27, the Senate LHHS Appropriations Subcommittee included the
port the Improving Access to Clinical Trials Act, please visit the advocacy
same allocation for the NIH as the House bill and the President's Budget.
section of the IMF website at www.advocacy.myeloma.org.
The Senate allocation for the NCI was $5.257 million. This amount is
Resolution Introduced Recognizing September
$153 million above the FY 2010 funding level. For the Geraldine Ferraro
Blood Cancer Program at the CDC, the Senate included $5 million for the
as Blood Cancer Awareness Month
program in FY 2011 (an increase of $300,000).
Representatives Walther Jones (R-NC) and Betsy Markey (D-CO) intro-
duced a resolution (HRes 1433) designating September 2010 as Blood
The IMF is working with Congress to ensure that these programs
Cancer Awareness Month. HRes 1433 highlights the impact that blood
receive the highest possible funding allocation in FY 2011. For more
cancers have in the United States each year and encourages greater sup-
information about these programs and IMF's FY 2011 appropriations
port for blood cancer research and education. For HRes 1433 to move
activities, please visit the advocacy section of the IMF website at
forward, at least 100 members must commit their support to the resolu-
www.advocacy.myeloma.org.
tion before it will be called up for a vote. At press time, this resolution has
59 cosponsors. To find out if your Representative supports Blood Cancer
Awareness Month, please visit the advocacy section of the IMF website at
www.advocacy.myeloma.org.
ConTinues on Page 16
The IMF Advocacy Voice
Get Fired Up! Raise Your Voice! Get Out There and Take Action!
This Fall, The IMF is rolling out an even bigger and better advocacy training
program and we want YOU to be a part of it. Learn when to act, what to say,
Based on our "Cancer
who to contact, why it's important, and how to go about making a difference.
Patient Statement of
Our team will provide you with the tools and preparation you need to help fight
for issues that affect YOU and the myeloma community.
Principles," the IMF
calls on the US Congress
More details on our program coming soon, including:
and the White House to:
· Program features · Course descriptions
· Dates and times · and more!
Ensure equality of access for all cancer patients;
Reform and streamline policies and procedures
Take the first step and sign up NOW for the
for early approval of new cancer treatments;
MyeloMa action network to stay informed
Support innovation to develop more effective cancer
of critical issues affecting the myeloma community.
treatments; and
Visit www.advocacy.myeloma.org.
Support research uncovering the causes of cancer.
800-452-CURE(2873)
15
Education & Awareness
rICHArDS / SEXUAL DYSFUNCTION -- continued from page 10
menopause in younger women. Vincristine and cisplatinum temporarily
sexual disorder is decreased libido. Women have reported improved
or permanently damage parts of the central nervous system leading to ED
libido, increased energy and sense of well-being with testosterone replace-
and ejaculation difficulties.
ment. However, there are potential risks and side effects with the use of
testosterone and other androgen therapies. Such therapies are not appro-
There is anecdotal evidence that sexual dysfunction is an occurrence with
priate for postmenopausal women who have a history of breast or uterine
novel therapies being used in myeloma. Reports of ED and decreased
cancer or those who have cardiovascular or liver disease.
libido in patients receiving bortezomib and lenalidomide are becoming
a common experience with practitioners treating myeloma patients.
What about fertility preservation in myeloma?
Thalidomide has documented evidence of ED. The restricted use of both
Chemotherapy and radiation may lead to infertility in 30-75% of male
thalidomide and lenalidomide may have psychological effects due to the
patients. In women, the effects of chemotherapy and radiation may lead
knowledge these drugs may cause birth defects.
to premature menopause thereby leading to a loss of fertility. Currently,
In addition, myeloma patients may require a bone survey to determine if
the American Society of Clinical Oncology (ASCO) recommends sperm
there is a current or pending fracture contributing to pain or causing risk
cryopreservation for male patients and embryo cryopreservation for
during sexual activity.
female patients. Other options may be offered at specialty centers. Patients
interested in preserving their fertility should discuss this with their health-
What are the treatments of male sexual dysfunction?
care provider.
Oral medications have been shown to improve ED, the most common
male sexual problem. However, in patients currently receiving nitrate
Any closing comments?
therapy, the use of of those medications is an absolute contraindication.
There is a need for improved communication between doctors, nurses,
Other ED interventions include intracavernous or transurethral injections,
and patients around sexuality issues. Do not be concerned about ask-
testosterone replacement, vacuum erection devices, surgical interven-
ing questions or describing changes in your sexual function to your
tions, and/or psychotherapy. It is important to note that the use of intra-
healthcare provider. A referral to a gynecologist or urologist, or clinical
cavernous or transurethral injections is an absolute contraindictation in
psychologist, certified sex therapist, or marriage and family therapist may
patients with myeloma and certain other conditions.
be appropriate. Sexuality is an important part of overall well-being and
open communication with your partner and with your healthcare provider
What are the treatments of female sexual dysfunction?
is essential in treating the underlying cause of the problem. mt
Studies have indicated that 30-50% of women have sexual problems result-
ing in distress and interpersonal difficulty. The most common female
ADvOCACY -- continued from page 15
Congressional Schedule
affect the myeloma community? Please visit the advocacy section of the
for Remainder of 2010
IMF website at www.advocacy.myeloma.org and join the Myeloma Action
Network to automatically receive e-mail advocacy alerts from the IMF. mt
After the August recess, Congress will return September 13th for a brief
pre-election session scheduled to end on October 8th. Congress will
How to contact the IMF Advocacy Team
spend some of this time passing a Continuing Resolution (CR) to fund the
federal government after the federal FY begins on October 1st. Congress
Christine Murphy Director, Government Relations
Phone: 703-738-1498
Fax: 703-349-5879
will reconvene after the midterm elections for a lame-duck session begin-
Email: cmurphy@myeloma.org
ning on November 15th. The session is expected to last one week. After
a break for the Thanksgiving holiday, Congress will reconvene again on
November 29th. This post-election work period will deal with potential
Arin Assero Director of Advocacy
recommendations from the deficit reduction commission set up by
Phone: 800-452-CURE (2873) ext. 232
Fax: 818-487-7454
Email: aassero@myeloma.org
President Obama as this commission may deliver a package of budget pro-
posals to Congress in December. Additionally, the FY 2011 Appropriations
will also be considered during the lame duck session. A target date for
Meghan Buzby Advocacy Assistant
adjournment of the lame duck session has not been set.
Phone: 410-252-3457
Email: mbuzby@myeloma.org
Are You a Member
of the Myeloma Action Network?
Would you like to stay informed about IMF's advocacy activities and learn
more about health care reform and other important advocacy issues that
16
www.myeloma.org
Support Groups
peopLe heLping peopLe
You are never alone in your bat le against myeloma
By Jim Barth, Founding Member, Tampa / St. Petersburg Multiple Myeloma Education Group
2010 IMF Annual
Kumamoto Associates, who served as our meeting facilitator for yet
Support Group Leaders' Summit
another year. We talked about the tools and information we wished to
This year's IMF Support Group Leaders' Summit commenced at 1 p.m.
take back to our local support groups and the successes, opportunities,
on July 23rd at the Four Seasons Resort & Club Dallas at Las Colinas, in
problems, and challenges that we encounter in the course of working
Irving, TX. In my brief recap, I will attempt to share with you some sense
with our groups.
of the events and conversations that took place during the Summit.
Next, Peter Radovich of Onyx Pharmaceuticals talked about carfilzomib, a
The Friday sessions started with a discus-
new proteasome inhibitor in develop-
sion led by Dr. Brian G.M. Durie. He talk-
ment for myeloma. (For more informa-
ed about the aspects of myeloma that have
tion, please read the interview with Dr.
become quite common now that patients
David Siegel on page 8 of this issue of
are living much longer with the disease.
Myeloma Today.) Phase III clinical tri-
He stressed that, beyond having a cancer
als are enrolling patients, but there is
doctor, it is important for patients to
hope that this drug might get approval
work closely with a general practitioner in
based on results of the Phase II trials.
order to keep healthy outside of myeloma.
To round out the day, the attendees
In a separate session on Friday, Dr. Durie
were surveyed to determine what addi-
presented an update on the work of
tional services can be offered to the
the IMF's International Myeloma Working
IMF that would be of benefit to sup-
Group (IMWG), which consists of 134
port groups. A lot of thought went into
leading myeloma researchers from around
this, and the resulting consensus has
the world who collaborate on a broad
already led to new web portal services
range of myeloma research projects. Dr.
that promise to be very helpful.
Durie shared information about several
On Saturday, IMF's Arin Assero led
exciting consensus projects that IMWG
the discussion of myeloma advoca-
members are currently working on, as
cy efforts, with Greg Chesmore of
well as the work that took place at the
Support Group Leaders and IMF staff at the 2010 SGLS
Celgene Pharmaceuticals making key
recent IMWG gathering in Spain. For more information about the IMWG
points about state legislators and effective advocacy for oral cancer drug
meeting, please read the story on page 5 of this issue.
parity legislation. Of the myeloma drugs currently in development,
The presentation about clinical trials and their outcomes, as well as the
25-30% are oral medications and, with many health insurance plans stuck
related topic of maintenance therapy, were of much interest to the sup-
in Dark Ages, patients are subjected to higher out-of-pocket costs for oral
port group leaders at the IMF Summit. Other talking points included the
meds. The advocacy session addressed how to build relationships with
concept of taking a "drug holiday" to eliminate some side effects, the
our representatives and how to lobby effectively for the causes that affect
importance of establishing if there are other health issues in the picture
the myeloma community. I would encourage everyone to visit http://www.
besides myeloma (co-morbidities), balancing the tolerability and efficacy
advocacy.myeloma.org and register on the website, and talk to Arin if you
of anti-myeloma therapies, and clarifying patient and physician priorities
need help or guidance.
when treating myeloma.
The Summit agenda continued, including topics such as group manage-
Next, we listened to a presentation from Dr. Richard Kadota of Genzyme,
ment and sustainability, annual planning, fundraising, meeting agendas,
the company working with plerixafor (Mozobil®). Approved at the end of
burnout, involving members in group leadership and activities, coping
2008, plerixafor is a relatively new drug. It is used in combination with
with loss of members, reaching new patients, and promoting awareness
granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic
of myeloma and public awareness of the group's existence.
stem cells to the peripheral blood for collection and subsequent use in
The next presentation, by Kathy Gram, RN, of Millennium - The Takeda
an autologous stem cell transplant (ASCT) for myeloma. Plerixafor seems
Oncology Company, made us aware of the assistance and resources avail-
to be more effective when more stem cells needed, and it substantially
able from the makers of bortezomib (VELCADE®). This session rounded
reduces the time needed for apheresis, but it is important to ask your doc-
out a very busy morning and was followed by a break for lunch. The
tor whether you are collecting for one or two procedures. Another issue
afternoon was very productive, with the attendees dividing into smaller
articulated during the discussion was that the use of either thalidomide
breakout groups for in-depth discussions of the challenges and opportuni-
(Thalomid®) or lenalidomide (REVLIMID®) reduces a patient's ability to
ties we had articulated during the general assembly.
produce stem cells. A guide for patients is available at www.mozobil.com.
The IMF Support Group Leaders' Summit concluded on Sunday, with the
After a break, during which I had a chance to talk with Dr. Durie, the
participants looking forward to sharing the many great ideas and plans
Summit program resumed with an overview by Alan Kumamoto of
with their individual groups. mt
800-452-CURE(2873)
17
Investing in the Future
the brian d. novis Legacy society
By Heather Cooper Ortner
Everybody knows the Boy Scouts' motto: Securities
"Always be prepared." This message holds
Making a charitable contribution of appreciated securities, such as stocks
true in many aspects of life beyond camping
or bonds, simultaneously maximizes your deduction, avoids capital gains
in the wilderness and learning to tie knots.
taxes, and makes a significant gift to the IMF. Simply tell your broker to
Being prepared with end-of-life plans ensures
transfer the desired shares to the IMF, and inform the IMF of your security
that your wishes for your family and your
transfer.
estate are met swiftly and are as free from
complication as possible.
Other options
Planned giving also opens up an opportunity to support the International
Giving options also include charitable gift annuities, charitable lead trusts,
Myeloma Foundation (IMF) in a meaningful and fulfilling way through
and charitable remainder trusts.
the Brian D. Novis Legacy Society. Planned or deferred gifts to the IMF
Every donor who makes arrangements for a planned gift is recognized with
are symbolic of the future we are building for myeloma patients. Because
membership in the Brian D. Novis Legacy Society, which is named in honor
such gifts will be realized at a later date, the IMF can make future plans to
of the IMF's co-founder. By making a gift to the IMF in your Will, you will
expand and improve our life-saving programs.
make a lasting contribution to myeloma patients and their loved ones. mt
Making a planned gift can be an intensely personal experience as one
Editor's Note: We recommend that you speak with your personal legal,
considers their own legacy. Planned gifts can be arranged through a vari-
financial, and/or tax advisors when considering making any decisions
ety of "vehicles," many of which might entitle you to tax benefits. (Please
about your planned gifts. If you would like to discuss your personal situa-
consult your tax advisor when considering making this type of gift.) The
tion or to advise the IMF of plans you have already made, please contact
Heather Cooper Ortner at 800-452-CUrE (2873) or hortner@myeloma.org.
most popular planned gift vehicles include:
Bequests
One of the easiest ways to make a gift to the International Myeloma
Foundation is by leaving the IMF a bequest in your Will. You can (1) give
a specific amount of money to the IMF; (2) give a specific item of property
to the IMF; (3) give a specified percentage of your total estate to the IMF;
or (4) give a specified share of the "residue" of your estate to the IMF. (The
residue of your estate is that which is left over after all specific charitable
or non-charitable gifts have been made to your heirs.)
Life Insurance
Initially, when your life insurance was purchased, you had a need for the
Proof that Every Dollar Counts
benefits. However, you may not need the coverage today. To contribute
August 2010 marked the one-year anniversary of the IMF's recur-
your life insurance policy, simply name the IMF as its owner and benefi-
ring giving program, the Hope Society. Since its launch, the Hope
ciary. You can also name the IMF as beneficiary only, or partial beneficiary.
Society has attracted 102 members who have made a commitment
Living Trusts
to monthly or quarterly contributions that help to fund many of
the programs and services provided by the IMF on a daily basis.
By creating a living trust, you can provide for yourself and your loved
Currently, Hope Society donors range from those who give $5 per
ones, both before and after your death. You can arrange a contribution
month to those who give $250 four times a year. Collectively, Hope
through a living trust by naming the IMF as a beneficiary.
Society donors have given more than $10,000 over the past year
Retirement Plans
proving that even a little bit can go a long way!
Tax-favored retirement plans, such as an IRA or 401(k), have become an
Becoming a Hope Society member is simple. Donors complete a
increasingly popular way to save money for retirement. If you choose to
form that notifies the IMF how much they wish to contribute on
name the IMF as a beneficiary of your retirement plan, you can avoid a
a monthly or quarterly basis, as well as their preferred method of
possible double taxation on retirement plan assets left to your heirs.
payment. The IMF takes care of the rest.
Real Estate
For 20 years, the IMF has been the center of education and support
for myeloma patients and family members who rely on our services.
A charitable contribution of real estate a personal residence, farm, vaca-
In a similar way, the IMF depends on its donors to help continue
tion home, commercial real estate, or vacant land is a gift with income
and improve upon those services. Members of the Hope Society
and capital gains tax advantages. You can contribute a remainder interest
understand this, and together ensure that "Until there is a cure...
in your property to the IMF, ensuring that the IMF will take possession of
there is the IMF." mt
the property upon your passing, while maintaining lifetime use of your
property.
Editor's Note: To join the Hope Society, call the IMF Development
department at 800-452-CUrE (2873) or email randi Lovett at
rlovett@myeloma.org.
18
www.myeloma.org
Member Events
imf members raise funds to benefit myeLoma community
By Suzanne Battaglia
In 2010, the IMF is
organizing an event in your community, you
time, imagination, and hard
proud to mark its
are also raising public awareness and helping
work to benefit the myeloma
20-year anniversary
those whose lives have been touched by this
community. Our FUNdraising
of service to the
disease. You want to do something in your
program provides you with
myeloma community.
community, but deciding on what to do and
the tools, assistance, and expertise to make your
Our membership is
how to do it can be confusing. That's where we
event a success. Choose an established event
a network of people
come in! The IMF's Fundraising program is here
model or create your own no idea is too large
like you, from across
to help you every step of the way. We make it as
or too small. Join us in working together toward
the country and around the globe. Many IMF
easy as possible for you to be involved, whether
our common goal... a CURE. Please contact me,
members are raising money for myeloma
or not you have any previous experience with
Suzanne Battaglia, at sbattaglia@myeloma.
research and educational programs that have
such activities.
org or 800-452-CURE (2873). I am here to chat
an impact on the lives of patients and family
with you about any ideas you might have. Be
FUNdraising is fun and easy to do, and brings
members worldwide.
part of making miracles happen!
with it the satisfaction of knowing that YOU
Being involved is very fulfilling and empowering.
have made a difference in many lives. We are
Here is just a sampling of some past and
Join us in our search for a cure for myeloma. By
grateful to all IMFers who contribute their
upcoming events...
Carolyn Czerkies Charity Golf Outing
research project and connecting with the grant recipient. The research
Since 2008, brothers
grant will be awarded at a ceremony during the annual meeting and
Craig, David, and Scott
exposition of the American Society of Hematology (ASH) in December
Czerkies have organized
2010 in Orlando, FL.
fundraising events as a
On the Fritz
tribute to their mother
On August 22, I was delighted to com-
to benefit the efforts of
bine business with pleasure when I
the IMF. Carolyn Czerkies
attended "On The Fritz," a one-man
passed away in 2000 from
Ed, Scott, Dave, and Craig Czerkies
show by Fritz Coleman at the El Portal
complications brought on by multiple myeloma. The goal of the Czerkies
Theatre in North Hollywood, CA. Fritz
brothers, their father Ed, and the rest of the Czerkies family was to reach
is a friend and California's broadcast-
the $40,000 donation level to fund the IMF's Junior Research Grant to be
ing icon, appearing on both KNBC-TV
awarded in the name of Carolyn Czerkies.
in Los Angeles and KNSD-TV in San Diego. He has been named "Best
The Czerkies Family organized their 2010 fundraising event the third
Weathercaster" in nearly every major paper in Southern California, and is
annual Carolyn Czerkies Charity Golf Outing to take place on Jun 5 at the
the honorary Mayor of Toluca Lake.
Whitetail Ridge Golf Club in Yorkville, IL. In addition to the funds raised
Fritz devotes much of his free time to charitable activities and frequently
over the past two years with the generous support of participants, spon-
organizes evenings of entertainment for local organizations. As a stand-up
sors, and volunteers, the outcome from the 2010 golf outing surpassed
comic, he has performed at clubs throughout Southern California, and
the Czerkies' original aim of raising a total of $40,000 to fund a myeloma
has written, produced, and starred in several one-man stage plays. Fritz
research grant. "It was always a goal of ours to help advance myeloma
has won a number of awards and honors for his dedication to community
research until a
service, and has received four Los Angeles area Emmy Awards for his work
cure for this dis-
on the NBC4 comedy specials and series.
ease is in sight,"
says Craig Czerkies.
As a special event for members of the IMF, Fritz performed his ever-evolv-
"Needless to say, it
ing one-man show, offering a witty inside look at LA weather, life-style,
is incredible news
and television news. The audience enjoyed his ascerbic comedy, followed
that our family
by Fritz's candid answers to their questions about the news business,
will be funding a
weather, and life under the California sun in the public eye.
myeloma research
"Through my friendship with Suzanne, I became educated about multiple
project in honor of
myeloma, a disease I had never heard of before," says Fritz. "Myeloma is
our mother!" The
a heartbreaking illness and I wanted to do something for those who are
family looks for-
coping with it. I don't know how much money I can raise to benefit the
The Czerkies Family: (back row) Charlie, Ed, Lanie, ward to learning
Scott, Dave and (front row) Miles, Laura, Louie,
IMF, but I can certainly help raise awareness. So we promoted the IMF on
about the chosen
Sandra, Cole, Craig, and Bonny
ConTinues on Page 20
800-452-CURE(2873)
19
Member Events
MEMBEr EvENTS -- continued from page 19
the show's website and IMF staffers handed out literature to theatre-goers
Hamilton Manor, The Miss New Jersey Education Foundation, Red Carpet
at the venue. Since I didn't want the amount of my donation to be predi-
Pageant and Prom, Pro-Video, MAE Celebrity Services, and Victoria's
cated on ticket sales in a difficult economy, I decided to make a personal
TV and Appliances. "Producing the cabaret show was a challenge, so it
contribution to the IMF on behalf of my family to help support the good
was very gratifying to hear audience members comment on how much
works of the IMF." Thank you Fritz for your generous donation to the
fun they had and that they were looking forward to coming to next
IMF and for your help with informing and educating the general public
year's show. My goal now is to make Cabaret for a Cure an annual event
about myeloma!
for the IMF!"
Cabaret for a Cure
Timberwolves 5K Run/Walk for Research
Courtney Charatsaris' uncle, Richard Venezia, was diagnosed with multiple
Julianne Basques first heard the words "mul-
myeloma three years ago. "We are very close. He is like an older brother
tiple myeloma" when her mother, Clara
to me, a true role model," says Courtney. "When he was diagnosed,
Basques, was diagnosed with the disease in
everyone in the family felt devastated. Since I did not qualify as a donor
1988. Although her mother succumbed to
for Richard's stem cell transplant, I wanted to find some other way to help
the disease in 1996, Julianne's desire to show
my uncle." Courtney is a theatre major at Montclair State University and a
her support for other patients and caregivers
competitor in the Miss New Jersey 2010 pageant, a scholarship organiza-
who are coping with myeloma, as well as her
tion within the Miss America system. (In June, Courtney was awarded the
understanding of the need to raise myeloma
Miss Congeniality prize and plans to participate in the pageant again in
awareness among the general public, led
2011.) "Naturally, I chose myeloma as my platform issue. I wanted to raise
her to initiate the Timberwolves 5K Run/
funds for myeloma research and for other programs that support myeloma
Walk for Research. The event took place on May 22 near Yosemite Park
patients and caregivers who are going through the struggles that my own
in Groveland, CA. Many members
family is experiencing."
of the Basques Family and their
supporters were in attendance.
"Julianne did an incredible job of
organizing and carrying out this
very special event," says her father.
"I was very touched by her speech
to the run/walk participants as
she described how myeloma has
affected our family in general and
the impact it had on her life in
particular. Julianne spent untold
hours putting together this 5K for
a great cause. I am very proud
of her." The IMF would like to
second Tony Basques' sentiment
and thank Julianne for her time
Jennifer Wilson, Chris Latini, Kayt Supple, Courtney Charatsaris,
and effort. Julianne's first ever event raised almost $3000 to support IMF
Scott Baird, Kaitlin Davis, Natalie ragazzo, Alaina Dill,
Kayla James, and Lindsay Stewart
programs and services, and we hope that this success will encourage her
to do it again in 2011.
In the midst of school commitments, theatre work, and a part-time job,
mt
Courtney managed to put together her very first fundraising event by pro-
ducing a cabaret show to benefit the IMF. The show took place on April
UPCOMING MEMBER EVENTS
18, 2010 at Hamilton Manor in Hamilton, NJ. "We charged $35 for dinner
October 20, 2010 Coach Rob's Charity Golf and Benefit Bash
and the show. In addition, we held
Rock Springs Ridge Golf Club Apopka, FL
a drawing for prizes that featured
Contact: Rob Bradford at rbradfdird@crothall.com
Yankee tickets and various sports
October 20, 2010 A Celebration of Life at Kasbah Phoenix, AZ
memorabilia, as well as gift baskets
Contact: Allan Weinstein or visit celebrationoflife.myeloma.org
from local vendors. We received tre-
October 30, 2010 An Autumn Tea Temecula, CA
mendous support from the com-
Contact: Debra Schuitt at 951-506-0610
munity, especially from the Spiral
November 6, 2010 Misbehave for Myeloma
Binding Company, our main spon-
Harry Caray's Italian Steakhouse Wrigleyville, IL
Contact: Alexandra Zousmer at aezous@gmail.com
sor. Our thanks also go to The Rech
Center for Performing Arts, The New Performers from The rech Center
November 6, 2010 Texas Hold `Em Benefit Bash San Jose, CA
for Performing Arts dance studio
Contact: Jack Aiello at jackaiello@comcast.net
Devils, The New Jersey Nets, The
in Hamilton, NJ
20
www.myeloma.org
IMF Staff Updates
introducing our neWest staff members
Betty
Alci Avelar
Phil Lange
Arevalo
Inventory Control
Accounting
Database &
Associate
Philip Lange brings
Inventory Control
Alci Avelar moved
over 20 years of
Betty Arevalo is a
to the United States
accounting experi-
Licensed Vocational
from El Salvador at
ence to IMF. He
Nurse (LVN). For
age 11. In college,
graduated
from
three years prior to
he studied drafting
Loyola
Marymont
joining the IMF, she
and design, but has
University in 1979.
provided patient care
spent the last six
Phil has extensive
at CHA-Presbyterian
years working in the
accounting experi-
Medical Center and at a convalescent home for
automobile industry, most recently as a nation-
ence, working for a wide variety of compa-
disabled and sub-acute patients in Los Angeles,
wide inventory coordinator in the corporate
nies in entertainment, commercial real estate
CA. Betty is working towards her Registered
offices of a major car dealership. At the IMF,
development, banking, manufacturing, publish-
Nursing (RN) degree while continuing her
Alci assembles and mails out information about
ing, non-profit, and healthcare. Phil is excited
commitment to the IMF. At the IMF, Betty helps
myeloma disease and treatment options, as well
about working with the incredible team at
maintain the computer database and stock
as IMF merchandise, in response to requests
IMF. Phil and Steve, his life partner of 18
inventory, and prepares materials for all IMF
that arrive at the IMF via phone and web. Alci
years, were legally married in California on
meetings, seminars, and conferences. In addi-
also works with IMF management and staff with
July 24, 2008. This year, they rescued a pair of
tion, she answers Spanish-language IMF Hotline
their inventory and shipping needs. In addi-
American Rat Terriers named Jocko and Oreo.
calls, assists Spanish-speaking participants at
tion, being fluent in Spanish, he has become
To contact Phil, please call the IMF or email
IMF Patient & Family Seminars, and coordinates
involved with IMF outreach efforts to serve
plange@myeloma.org.
Spanish myeloma support group meetings.
the Spanish-speaking myeloma community. To
To contact Betty, please call the IMF or email
contact Alci, please call the IMF or email
marevalo@myeloma.org.
aavelar@myeloma.org.
Do you have a question?
Perhaps you would like to order a publication? Are you thinking about registering for
a Patient and Family Seminar or Regional Community Workshop? Would you like to
download the Myeloma ManagerTM? All this and MORE is possible on the IMF website.
www.myeloma.org.
Gems for Myeloma
Imagine Moving Forward is the theme of the IMF's
Handcrafted by Marya Kazakova, IMF's
myeloma bracelet. Wear one in honor, celebration, or in memory
Publications Editor, this beautiful jewelry is
of a loved one. When
available for sale to raise funds for the IMF.
people ask you about
The triple toggle design features interlocked
it, you'll have a perfect
14K gold-filled loops with your choice of
opportunity to spread
cultured freshwater pearls or faceted round
the
word
about
gemstone beads. The toggle measures approximately
multiple
myeloma.
1.75" long. The earrings dangle from 14K gold-filled French wires
These bracelets are
(for pierced ears only), and the pendant hangs
only $1 each in sets
on a 14K gold-filled 16" ball chain.
of 10. Youth bracelets
Choose white cultured freshwater pearls, blue
are now available, so
Amazonite, purple Amethyst, green Aventurine,
everybody in your
honey Carnelian, or Garnet in the IMF's
family who has been
signature burgundy color!
touched by myeloma can wear one! Order bracelets online at
our website www.myeloma.org, or contact Suzanne Battaglia at
To order, call the IMF or visit
www.myeloma.org/store/product62.html
SBattaglia@myeloma.org or 800-452-CURE (2873).
800-452-CURE(2873)
21
International Myeloma Foundation
NON-PROFIT
12650 Riverside Drive, Suite 206
ORGANIZATION
North Hollywood, CA 91607-3421
U.S. POSTAGE
U.S.A.
PAID
www.myeloma.org
N. Hollywood, CA
(800) 452-CURE (2873)
PERMIT NO. 665
Change Service Requested
Foundation
Myeloma
International
©2010,
U.S.A.in
Dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure.
Printed
2010 / 2011 IMF Calendar of Events
2010
Oct 15-16
MMHÖ/IMF Patient & Family Seminar Vienna, AUSTRIA
Dec 4-6
American Society of Hematology (ASH) Orlando, FL
Oct 16
IMF Regional Community Workshop Raleigh/Durham, NC
Dec 16
IMF Regional Community Workshop Stut gart, GERMANY
Oct 18
IMF Patient & Family Seminar Bologna, ITALY
Dec 18
IMF Patient and Family Seminar Würzberg, GERMANY
Oct 21-23
Southwest Oncology Group (SWOG) meeting Chicago, IL
Dec 21
IMF Regional Community Workshop (Physicians)
Oct 23
IMF Regional Community Workshop Overland Park, KS
Münster, GERMANY
Oct 23
Myeloma Canada Patient, Family, & Healthcare
2011
Professionals Conference Richmond, BC, CANADA
Feb 25-26
IMF Patient & Family Seminar Boca Raton, FL
Nov 5-7
Eastern Cooperative Oncology Group (ECOG) meeting
Ft. Lauderdale, FL
March 11-12 IMF Patient & Family Seminar San Francisco, CA
Nov 13
4th Annual Comedy Celebration Los Angeles, CA
Aug 26-27
IMF Patient & Family Seminar Philadelphia, PA
Additional events/meetings wil be posted in later editions of Myeloma Today as dates are finalized.
For more information, please visit www.myeloma.org or cal 800-452-CUrE (2873).
IMFLatin America, IMFJapan and IMFIsrael events are not included above.
Thank you for your continued support of the IMF.