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Myeloma Minute - November 13, 2007
11.13.07
Welcome to the IMF's Myeloma Minute
News about myeloma treatment, research, support and the myeloma community
from the International Myeloma Foundation.

WHAT'S NEWS

Revlimid® Receives Recommendation for Approval from Australian Drug Evaluation Committee for Treatment of Myeloma
The recommendation for approval from the ADEC was based upon the safety and efficacy results of two large, randomized pivotal Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating REVLIMID plus dexamethasone in multiple myeloma patients whose disease has progressed after one therapy. (from Celgene)


Curry in a healthy hurry
Turmeric back in the news. A growing body of research indicates that curcuminoids, the active components in turmeric, could be used to prevent a wide range of illnesses, from colorectal cancer to Alzheimer’s disease to arthritis and skin disorders. (from The Star in Malaysia)


ASCO Publishes Guidelines for Preventing and Treating Venous Thromboembolism (VTE) in Cancer Patients
The guidelines, which are based on studies that have been reported in the medical literature, will be published in the December 1, 2007 issue of the Journal of Clinical Oncology. They will also appear early online on the American Society of Clinical Oncology Web site on October 29, 2007. It is estimated that VTE affects four to 20 percent of cancer patients. (from Science Daily)

MEDICARE NEWS
It's enrollment time for 2008 Medicare Part D plans, and if seniors are not careful, they could find themselves with hefty new co-payments.

  • Seniors must shop as Medicare drug premiums rise
    Starting this week, those eligible for Medicare can begin enrolling in the optional drug plan for 2008, with a dizzying array of choices — and potential premium increases for 74% of those who currently have a stand-alone drug plan.. (from USA Today)

  • Out of Pocket Comes Bitter Pill
    According to a study by the consulting firm Avalere Health, monthly premiums are increasing 21 percent on average for prescription plans, with many of the steepest rises coming in those that have had the lowest premiums. (from the Baltimore Sun Times).


Excess Pounds Raise Women's Cancer Risk
The Million Women Study studied over one million women in the UK over seven years. The researchers found that excess weight increased the risk of developing myeloma by 50%. (from US News and World Report)

Cognitive function recovers after stem cell transplant
Cancer patients appear to show negative changes in cognitive functioning associated with hematopoietic stem cell transplantation (HSCT), but values return to a normative level within a year. (from Reuters Health by way of Oncolink)

ADVOCACY NEWS
by Christine Murphy

FDA Issues New Warnings On Drugs Used To Treat Anemia

FDA officials added new warnings to anemia treatments that the agency said are consistent with a new Centers for Medicare and Medicaid Services reimbursement policy that some lawmakers are trying to overturn. In contrast to FDA, the drug company Amgen is using the new warnings to request CMS to reconsider its coverage determination. John Jenkins, director of FDA's office on new drugs, summed up the new information as a warning that physicians should use the treatments in cancer patients only to avoid blood transfusions and that doses should remain low to mitigate side effects. He noted that lower doses have not yet been studied. While the new alert warns against using the anemia drugs at doses achieving a hemoglobin level of 12 grams per deciliter or higher, CMS limits payment at hemoglobin levels of 10 grams per deciliter. Amgen said it will request CMS revise its reimbursement policy based on the 10 and 12 grams per deciliter difference, as well as other evidence the company will submit.

CMS recently issued a national coverage determination limiting reimbursement to doses achieving hemoglobin levels of 10 grams per deciliter or less, based on data showing transfusions generally occur at hemoglobin levels between 7 and
8 grams per deciliter and the studies revealing the drugs could be dangerous at hemoglobin levels of 12 grams per deciliter or greater. Senate Finance Chairman Baucus and Reps. Anna Eshoo, D-Calif., and Mike Rogers, R-Mich., have introduced resolutions to overturn CMS' new policy. They assert that CMS' policy takes flexibility away from physicians to treat patients on a case-by-case basis. A Baucus aide would not comment on the new warnings and Eshoo's and Rogers' offices did not respond to requests for comment.

The new box warning emphasizes that recent studies found the drugs speed tumor growth and shorten survival in patients with certain cancers who use the treatments to achieve higher levels of hemoglobin. An earlier warning described six studies that showed the expedited tumor growth and shortened survival, but specify the types of cancer affected or that quality of life is not shown to improve. A warning also clarifies that the treatments should be used only on patients undergoing chemotherapy and should be stopped as soon as the treatment ends.

FDA also added new warnings to anemia treatments for chronic kidney failure that hemoglobin levels should remain between 10 and 12 grams of hemoglobin per deciliter. Higher hemoglobin levels can lead to serious cardiovascular risk such as heart attack, stroke and heart failure. Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit are affected by the new warnings.

This is the fifth time FDA has approved updated labeling information since Epogen and Procrit were approved in 1989, said Robert Pazdur, head of FDA's oncology drug products office. Today's changes were based on two earlier advisory panel meetings.

Read on:


WHAT'S NEW IN RESEARCH
ARTICLES
(IMF Scientific Advisors are marked with an *)
  • Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial
    Paul G. Richardson*, Pieter Sonneveld*, Michael Schuster, David Irwin, Edward Stadtmauer, Thierry Facon, Jean-Luc Harousseau*, Dina Ben-Yehuda, Sagar Lonial, Hartmut Goldschmidt*, Donna Reece*, Jesus San Miguel*, Joan Blade*, Mario Boccadoro*, Jamie Cavenagh, Melissa Alsina, S. Vincent Rajkumar*, Martha Lacy, Andrzej Jakubowiak, William Dalton, Anthony Boral, Dixie-Lee Esseltine, David Schenkein, and Kenneth C. Anderson*
    Blood 2007;110 3557-3560
CLINICAL TRIALS
  • VELCADE® trials

  • THALOMID® trials

  • REVLIMID® trials

  • DOXIL® trials

  • Phase II study of CC4047 (formerly “Actimid”) for patients with relapsed disease who have had 3 or fewer previous regimens.  The study is being conducted by Dr. Martha Lacy at the Mayo Clinic in Rochester, MN.  If you are interested, please contact Dr. Lacy’s study assistant, Melanie Thompson, at 507-266-0733.  The trial opens Friday, November 9th.

  • Phase Ib
    Drug name: SGN-40
    Sponsor: Seattle Genetics
    Indication: Open-label, single-arm study of SGN-40 in escalating doses in combination with Revlimid and dexamethasone for patients with rel/ref mm.

  • Phase I
    Drug name: RHAMM-R3 peptide (ILSLELMKL)
    Sponsor: University of Ulm, Germany, et al.
    Indication: Vaccine study with a CD8+ T cell epitope peptide derived from RHAMM for patients with AML, MDS, and MM.

  • Phase III
    Drug: tanespimycin (KOS-953)
    Sponsor: Kosan Biosciences
    Indication: Phase III open label trial for patients with multiple myeloma in first relapse. Trial will compare tanespimycin (KOS-953) in combination with a fixed dose of bortezomib (Velcade) versus bortezomib alone.

  • Phase II/III
    Drug: tanespimycin (KOS-953)
    Sponsor: Kosan Biosciences
    Indication: Phase II/III randomized, open label trial for patients with relapsed/refractory multiple myeloma.  Study agent is tanespimycin (KOS-953) at three different dose levels in combination with a fixed dose of bortezomib.


If you would like more information about any clinical trial, you can call the IMF Hotline at 800-452-CURE. The Myeloma Matrix has a current list of all myeloma trials from pre-clinical to recently FDA approved. If you would like to browse trials currently open for enrollment, visit the Clinical Trials page of the IMF web site. Among the links, you will find EmergingMed, with whom the IMF has entered into a partnership to assist you in matching trials to your particular patient profile (i.e., stage of disease, previous treatment, how well you are able to carry out the activities of daily living, etc.) and by doing so, increase your chances of being eligible. You can also learn more about clinical trials by reviewing materials from the National Cancer Institute.

UPCOMING SEMINARS AND CLINICAL CONFERENCES
Düsseldorf Regional Community Workshop - Düsseldorf, Germany
November 17, 2007
Berlin Regional Community Workshop - Berlin, Germany
November 19, 2007
Little Rock Regional Community Workshop - Little Rock, Arkansas
December 1, 2007
Planning for Treatment With or Without Transplant: Balancing Efficacy, Toxicity, and Quality of Life for the Patient with Multiple Myeloma
Save the Date! Friday Satellite Symposium on December 7, 2007 preceding the 49th ASH Annual Meeting
.
St. Louis Regional Community Workshop - St. Louis, Missouri
December 15, 2007
Atlanta (Buckhead) Patient & Family Seminar - Atlanta, Georgia
February 15-16, 2008

UPCOMING EVENTS
The IMF's comprehensive "How-to-FUNdraise" guide is what you need if you're thinking about fundraising in your community but don't know where to start. The guide contains the A - Z of fundraising ideas--like running in a local marathon and asking for donations per mile for myeloma; having a holiday party, where you charge a cover and hold a raffle; asking your local supermarket to donate wine and cheese, then selling tickets and having a cocktail party--as well as tips and guidelines for success. Check out the FUNdraisers below and show your support by donating to their effort online:
Jammin' for a Cause - Elko, Minnesota
November 17, 2007

Multiple Myeloma Night with the Philadelphia Phantoms - Philadelphia, Pennsylvania
December 14, 2007

An Evening of Believing - Lewisville, Texas
February 23, 2008
Commissions for Chris: A Campaign to Honor Chris Hollyer
Jo Marie Gray is donating her new-client commissions from the sale of Arbonne Cosmetics to the Chris Hollyer Research Fund at the IMF.
Cents for Cells
Beth Morgan is helping the IMF by raising a penny for each stem cell that will be collected for her BMT. She has dedicated Cents for Cells to the memory of Chris Hollyer.
Clyde's Ride for the Cure
Clyde is riding his bicycle to support the work of the IMF. "I say, 'until there is a cure I ride for the IMF.'"
Miles for Myeloma
Larry Bartolin is a six-year survivor of multiple myeloma, and is riding his motorcycle to raise funds and public awareness.
Losing Weight to Gain Awareness
Debi is losing weight to raise money for research and the awareness programs of the IMF.

VISIT THE IMF HOLIDAY BOUTIQUE
Time to start thinking about the coming holidays. Shopping in the IMF Holiday Boutique is the perfect opportunity to help your gifts give twice - once to the recipient, and once to the myeloma community through the IMF.
As a non-profit organization, the IMF is completely dependent on the support of our members. Tax-deductible donations in honor of a friend or family member make great gifts and are a wonderful way to celebrate a special occasion. You can donate online or by calling the IMF at (800) 452-CURE. And you can order beautiful tribute cards to send out to your friends and family every time you make a donation in their honor to the IMF.We sincerely thank you for your support.
Shop for the IMF
Shop with the leading merchants on the Internet, receive the same price as anyone else visiting their sites, and support the IMF at the same time!
European Holiday Markets
Each town you visit is like a gift just waiting to be unwrapped. Fragrances of roasted chestnuts, strudel, sugar-coated baked apples, and hot mulled wine at the Christmas Markets will tantalize your senses.

Read the latest issue of the IMF Travel Advantage newsletter for this and other fabulous trips. Great prices and you are helping the IMF with every vacation.
Difford Bracelets Multiple Myeloma Awareness Bracelets
Beautiful custom made jewelry to honor those who have joined the struggle against multiple myeloma.

Caregiver Daily Journal

Caregiver Daily Journal
If you know a caregiver, the IMF's own Sylvia Baca has written a journal to help document the daily care they give their loved one. It's $25, with all profits going to support the programs of the IMF..

Sarah Klein's Bracelets

Sterling Bracelets by Sarah Klein
Sarah Klein's father, Benson, was diagnosed with myeloma in 1998, and has been in remission for 8 years.
Sarah wants to give back to the IMF in her own creative way and has designed two special bracelets made up of semi-precious healing stones. A portion of the proceeds from the sale of these bracelets is being donated to the IMF.

IMF Christmas Cards With Original Jr. IMFer Art
Ten cards per box, five of each style.
Inside card reads: Warmest wishes for peace, love, health and happiness this Christmas and throughout the year.

Ribbon of Hope Ornament
Whether hanging on a holiday tree, a wall, or any other creative place you can think of, the IMF's Ribbon of Hope ornament will bring a message of hope to anyone you give it to.
Multiple Colors for Multiple Myeloma Keychains and Earrings
Bring rainbows of happiness, color and light into your loved ones' lives with an IMF keychain or Swarovski crystal earrings.

Arbonne Cosmetics
Jo Marie Gray is donating her new-client commissions from the sale of Arbonne Cosmetics to the Chris Hollyer Research Fund at the IMF.
IMF Logo Items
Let the world know that you support the groundbreaking research and innovative patient support programs of the IMF with a hat or shirt or bracelets!
See more exciting ways to help the IMF continue its important work in education, support and research.

ITEMS OF INTEREST

The National Cancer Institute (NCI), a federal agency that is part of the National Institutes of Health (NIH) and the George Washington School of Public Health, would like to talk to women who are providing care for a family member or friend with cancer. They’d like to learn about your caregiving experience and how you have coped. If you are:

  • Female
  • African American
  • Between the ages of 31 and 80
  • Currently providing care for someone over the age of 20 with cancer, OR you provided care for someone over the age of 20 with cancer at end-of-life within the last year

Call them toll-free at 1-888-249-0029 (Monday to Friday, 9am-5pm EDT)

They will ask you some questions about yourself and your caregiving experience. Participating in this study involves a total of 15-20 minutes by phone. If they qualify, eligible participants may be asked to provide additional information about their caregiving experiences in a follow-up telephone interview that will last approximately 45-60 minutes.


Help for Underinsured Myeloma Patients
Thanks to the advocacy of the IMF, the Chronic Disease Fund has received an infusion of money to help them meet the needs of underinsured patients with multiple myeloma. The fund is designed to help patients with their insurance co-payments and/or their Medicare Part D 'doughnut holes.' Patients must qualify based on financial need. To speak with a representative of the Chronic Disease Fund, please call 877-968-7233, or contact them through their web site at cdfund.org.

Mensajero del Mieloma
La IMF quiere enviar información sobre el mieloma en español a todos los pacientes, familiares e interesados. Para suscribirse al correo electró nico (enviaremos cuatro ejemplares al año), por favor, env íe su dirección a mensajero@myeloma.org. ¡Gracias!


BANK ON A CURE®

International Staging System

NexProfiler
A tool to help understand the current status of the disease and the questions you should be asking.

Check out HealthTalk's Multiple Myeloma Education Network and Andrew Schorr's Patient Power.

Sign up for a FREE Subscription to Myeloma Today, the
Official Newsletter of the IMF!

Many thanks to the supporters of The Myeloma Minute:
Celgene Corporation, Kyphon, Millennium Pharmaceuticals, Ortho Biotech, and The Binding Site.
Please call the hotline (800) 452-CURE (800-452-2873) or email TheIMF@myeloma.org if you have any questions.
Copyright 2002-2007. International Myeloma Foundation. All Rights Reserved.


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