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®
May 2008
atrix
The Current Status of VELCADE®
in U.S. and Foreign Clinical Trials
PHASE I · I/II · II · III · IV · Pilot
aM
International Myeloma Foundation
12650 Riverside Drive, Suite 206
North Hollywood, CA 91607-3421
yelom
Hotline (USA & Canada): (800) 452 CURE (2873)
Tel: (818) 487-7455
Email: TheIMF@myeloma.org
A publication of the International Myeloma Foundation
Website: www.myeloma.org
M
www.myeloma.org
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g r o . a
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o l e y m .
www
n o i t a d n u o F
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l a n o i t a n r e t n I e h t f o
n o i t a c i l b u p
A
.myeloma.org
www
ebsite:
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TheIMF@myeloma.org
Email:
y
487-7455
(818)
el:
T
(2873)
CURE
452
(800)
Canada):
&
(USA
Hotline
e
91607-3421
CA
Hollywood,
th
Nor
206
Suite
Drive,
Riverside
12650
l
Foundation
Myeloma
national
Inter
oma t o l Pi · V I · III · II · II/I · I SE AHP
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s l a i r T l a c i n i l C n g i e r o F d n a . .S U n i
E D A C L E V f o s u t a t S t n e r r u C e h T
®
a
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trix
®
· Phase I trial A trial designed to determine the MTD (maximum tolerated dose) of a new drug or
a new combination of drugs that has never been tried in humans. It is usually the first human testing
of a new treatment, although in Phase I trials of combination therapies, the individual elements may
already have been well tested. Patients in Phase I trials must have advanced cancer that is refractory to
Clinical trials are research studies of new treat-
any standard treatment. In a typical Phase I trial, successive groups ("cohorts") of 3 to 6 patients are
ments that involve patients. By testing new drugs or combina-
given the treatment. All patients in a cohort get the same dose.
tions of drugs, each study is designed to find better ways to
The first cohort typically gets a very low dose, and the dose is
prevent, detect, diagnose, or treat cancer, to improve the qual-
raised in each subsequent cohort until a set number of patients
ity of life of the patient, and to answer scientific questions.
experience DLT (dose limiting toxicity). The dose level used
for the previous cohort is then taken to be the Maximum
Many hospitals now take part in clinical trials, which are only begun after laboratory studies have out-
Tolerated Dose. This dose is then used in a Phase II trial.
lined the potential safety of a new treatment or procedure, and it has been found to have the potential
to work better than existing methods. Clinical trials vary greatly in size: from a single researcher in one
hospital or clinic to an international multicenter study with several hundred participating researchers on
· Phase II trial A trial designed to determine the response
several continents. The number of patients in a test can range from a few to several thousand.
rate of a new therapy that has already been tested in Phase
I trials. Typically, 14 to 50 patients with one type of cancer are treated to see how many have a
Some relevant definitions:
response. Patients are usually required to have advanced cancer that is refractory to any standard
· Control group The arm of a randomized clinical trial that gets the standard treatment.
treatment, and in addition, they must have measurable disease. If results from a Phase II trial are
promising enough, the treatment may then be tested in a Phase III trial. If the results are obviously
· End Point What a clinical trial is trying to measure or find out; the goal of the trial. Typical end
much better than the standard treatment, then it may not be necessary to do a Phase III trial, and the
points include measurements of toxicity, response rate, and survival.
treatment may become standard based on Phase II trial results.
· Experimental group The arm of a randomized trial that gets the new treatment.
· Randomized clinical trial A research study in which subjects are randomly assigned to receive a par-
· Phase III trial A trial designed to compare two or more treatments for a given type and stage of
ticular treatment.
cancer. The end point of a Phase III trial is usually survival or disease-free survival. Phase III trials are
usually randomized, so patients don't choose which treatment they receive. A typical Phase III trial
has 50 to thousands of patients. Some Phase III trials compare a new treatment that has had good
results in Phase II trials with an older, well known, standard treatment. Other Phase III trials com-
pare treatments that are already in common use. Some treatments in Phase III trials may be available
outside the clinical trial setting.
· Phase IV trial A trial focused on safety surveillance and ongoing technical support of a drug after
it receives FDA permission to be sold. Phase IV studies may be required by regulatory authorities
or may be undertaken by the sponsoring company for competitive reasons (such as, finding a new
market) or other reasons (such as, testing for interactions with other drugs, or on certain population
groups who are unlikely to join a trial themselves). The safety surveillance is designed to detect any
rare or long-term adverse effects over a much larger patient population and longer time period than
was possible during the Phase I-III clinical trials.
VELCADE®
U.S. Clinical Trials Update
Foreign Clinical Trials Update
May 2008
PHASE
TITLE
LOCATION
PHASE
TITLE
LOCATION
UARK 2006-66, Total therapy 3B: An extension of UARK 2003-33 Total therapy (2006-66)
Little Rock, AR
Bortezomib-doxorubicin-dexamethasone (BDD) as treatment for patients with multiple myeloma presenting with acute renal failure
Vienna, Austria
UARK 2006-15: A study of tandem transplants with or without bortezomib and thalidomide (2006-15)
Little Rock, AR
(VEL-EU-0038)
Study of multiple myeloma patients relapsing or progressing after autologous transplantation on Total therapy 2 (2006-05)
Little Rock, AR
Efficacy of bortezomib consolidation after high-dose melphalan with stem cell support in myeloma patients (NMSG 15/05)
Copenhagen, Denmark
multicenter
Phase III randomized study of melphalan and prednisone with versus without bortezomib in older patients with newly diagnosed
Los Angeles, CA
multiple myeloma (UCLA-0409110-01)
VELCADE and melphalan combination conditioning regimen for autologous peripheral blood stem cell transplantation in multiple
Toulouse, France
III
myeloma patients younger than 65 (2007-VEL-EU-0004)
multicenter
Randomized Phase IIIb study of three treatment regimens in subjects with previously untreated multiple myeloma who are not
New York, NY multicenter
considered candidates for high-dose chemotherapy and autologous stem cell transplantation: VELCADE (bortezomib), thalidomide,
Consolidation therapy with bortezomib in elderly patients with multiple myeloma (CR006127)
Germany multicenter
and dexamethasone (VTD) versus VELCADE, melphalan, and prednisone (MVP) ((UPFRONT)C05009)
Bortezomib as consolidation therapy in patients with multiple myeloma age < 60 years (CR006124)
Germany multicenter
Phase III randomized study of consolidation therapy comprising bortezomib and dexamethasone with versus without lenalidomide in
Philadelphia, PA
A Phase III, multicenter randomized open label study of VELCADE/melphalan/prednisone and thalidomide (V-MPT) versus VELCADE/
Torino, Italy multicenter
patients with symptomatic multiple myeloma who have completed a dexamethasone-based induction regimen (E1A05)
melphalan/prednisone (V-MP) in elderly untreated multiple myeloma patients (ITA-IIS-VEL-2005-11)
A study of tanespimycin (KOS-953) in patients with multiple myeloma in first relapse (KAG-301)
multicenter
VELCADE plus cyclophosphamide, dexamethasone, thalidomide (V-CDT) as induction therapy for newly diagnosed myeloma
Malaysia
Phase III randomized study of lenalidomide and low-dose dexamethasone with versus without bortezomib in patients
multicenter
patients who are autograft candidates (2006-VEL-AP-0021)
with previously untreated multiple myeloma (SWOG-S0777)
A randomized controlled study of VELCADE (bortezomib) plus thalidomide plus dexamethasone compared to thalidomide plus
Leiden, Netherlands
PHASE II
dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation (X05140)
multicenter
Phase II dose-response study of VELCADE and bone formation in patients with relapsed/refractory multiple myeloma (X05168)
Little Rock, AR
A randomized Phase III study on the effect of bortezomib combined with adriamycin, dexamethasone (AD) for induction treatment,
Rotterdam, Netherlands
followed by high-dose melphalan and bortezomib alone during maintenance in patients with multiple myeloma (HOVON X05164)
multicenter (ongoing site
UARK 2006-32 Phase II study of rapidly recycled high dose DTPACE (2006-32)
Little Rock, AR
enrollment)
A Phase II pilot study of the combination of (MEL-VTD) (2007-01)
Little Rock, AR
III
Bortezomib re-induction therapy combined with donor lymphocyte infusion in patients with relapsed myeloma following allogeneic
Utrecht, Netherlands
Phase II trial of cyclophosphamide, bortezomib, and dexamethasone in newly diagnosed symptomatic multiple myeloma (X05210)
Scottsdale, AZ
stem cell transplantation (2006-VEL-EU-0025)
multicenter
Phase II study of cyclophosphamide, bortezomib, and dexamethasone in patients with newly diagnosed active multiple myeloma
Scottsdale, AZ
VTD (VELCADE, thalidomide, and dexamethasone) induction followed by MPT maintenance for multiple myeloma (age > 65)
Incheon, South Korea
(MAYO-MC0686)
multicenter
(VEL-AP-0046)
Bortezomib followed by high-dose melphalan and bortezomib as conditioning regimen for tandem stem cell transplants
Tampa, FL
Sequential VAD (vincristin, adriamycin, and dexamethasone) and VTD (VELCADE, thalidomide, and dexamethasone) induction
Seoul, South Korea
(MCC-14184)
chemotherapy followed by high-dose therapy with autologous stem cell transplantation and maintenance therapy with VELCADE for
newly diagnosed multiple myeloma (VEL-AP-0045)
A combination high-dose melphalan and autologous peripheral blood stem cell (PBSC) transplant with bortezomib: a dose and
Atlanta, GA
schedule finding study (i063-341-03)
A national, open-label, multicenter, randomized comparative Phase III study of VBMCP-VBAD/VELCADE versus thalidomide/
Salamanca, Spain
dexamethasone versus VELCADE/thalidomide/dexamethasone followed by high dose intensive therapy with autologous hemopoietic
Phase II study to evaluate efficacy and safety of VELCADE plus dexamethasone administration of bortezomib in newly diagnosed
Boston, MA multicenter
stem cell (VEL-EU-0027)
multiple myeloma (X05153)
A national, open-label, multi-center, randomized comparative Phase III study of VELCADE/melphalan/prednisone versus VELCADE/
Salamanca, Spain
Bortezomib, lenalidomide, and dexamethasone combination therapy for patients with relapsed or relapsed and refractory
Boston, MA multicenter
thalidomide/prednisone and maintenance treatment with thalidomide versus prednisone in elderly untreated patients with mutliple
multicenter
multiple myeloma (06-147)
myeloma (VEL-EU-0031)
Phase II study of bortezomib, melphalan, and dexamethasone in patients with primary systemic amyloidosis or light chain
Detroit, MI
GEM05 for patients with multiple myeloma more than 65 years old (2005-001111-21)
Spain multicenter
deposition disease (WSU-2006-132)
GEM05 for patients with multiple myeloma under 65 years (2005-001110-41)
Spain multicenter
Phase II trial of twice weekly induction followed by once weekly IV VELCADE (bortezomib) with dexamethasone in patients
Lansing, MI multicenter
with relapsed and/or refractory multiple myeloma following at least one prior therapy(i071-341-03)
Bortezomib consolidation in patients with myeloma following treatment with high-dose melphalan and autologous stem cell support.
Gothenburg, Sweden
(VEL-EU-0083)
multicenter
Phase II study of induction therapy and maintenance therapy comprising bortezomib and dexamethasone in patients with relapsed or
Lansing, MI
refractory multiple myeloma (SPARROW-I071-341-03)
VELCADE, idarubicin and melphalan in patients with refractory/relapsed multiple myeloma (VEL-03-095)
Leeds, UK multicenter
A Phase II study of bevacizumab and bortezomib in patients with relapsed/refractory multiple myeloma (AV3502s)
Hackensack, NJ
First amendment to Myeloma IX study: bortezomib and dexamethasone in relapse (UK-VEL-13)
Leeds, UK multicenter
Phase II study of VDT (VELCADE, Doxil, and thalidomide) as frontline therapy for patients with previously untreated multiple
Buffalo, NY
PHASE II
myeloma (MM) (X05144)
Bortezomib-dexamethasone-doxorubicin-study (Eudract Number: 2005-003001-85)
Vienna, Austria
II
Phase II pilot study of bortezomib, doxorubicin hydrochloride liposome, and thalidomide as front-line therapy in patients
Buffalo, NY
multicenter
with previously untreated Stage I, II, or III multiple myeloma (RPCI-I-59105)
Phase II trial of bortezomib in combination with dexamethasone for relapsed multiple myeloma (VEL-AP-0094)
East Melbourne, Australia
Phase II clinical trial of bortezomib+liposomal doxorubicin+dexamethasone followed by thalidomide+dexamethasone
New York, NY
Bortezomib and dexamethasone as treatment and maintenance for multiple myeloma Relapse (05/69)
Melbourne, Australia
or bortezomib+thalidomide+dexamethasone for patients with symptomatic untreated high-risk or primary resistant multiple
myeloma (X05166)
A study assessing safety and effectiveness of bortezomib combination therapy (bortezomib + doxorubicin hydrochloride +
Canada multicenter
dexamethasone) in previously untreated multiple myeloma patients (CR10927)
Phase II study of VELCADE, Decadron, and Doxil followed by cyclophosphamide in multiple myeloma (0504007841)
New York, NY
Combination bortezomib-containing regimens in newly diagnosed patients with t (4; 14) positive multiple myeloma
Toronto, Canada
A sequential phase II trial of the combination of bortezomib (VELCADE), dexamethasone (DECADRON) and pegylated liposomal
New York, NY
(26866138-MMY-2016)
doxorubicin (DOXIL) followed by high dose cyclophosphamide in multiple myeloma patients (X05178)
Phase II study of cyclophosphamide, bortezomib, and dexamethasone in patients with newly diagnosed active multiple myeloma
Toronto, Canada
Phase II study of bortezomib, pegylated doxorubicin hydrochloride liposome, and dexamethasone followed by thalidomide
New York, NY
(MAYO-MC0686)
multicenter
and dexamethasone with or without bortezomib in patients with symptomatic high-risk or primary resistant multiple myeloma
(MSKCC-06067)
Phase II study of bortezomib/dexamethasone and high-dose melphalan in patients relapsing after high-dose melphalan and
Copenhagen, Denmark
autologous stem cell transplant (2006-VEL-EU-0030)
multicenter
Phase II study of melphalan and autologous stem cell transplantation followed by adjuvant bortezomib and dexamethasone in patients
New York, NY
with previously untreated systemic light chain amyloidosis (MSKCC-07006)
The efficacy of VELCADE on bone tissue during myelomatosis (bone marrow cancer) (2006/175)
Vejle, Denmark
An investigational drug, PD 0332991, is being studied in combination with VELCADE and dexamethasone in patients with multiple
New York
Treatment of multiple myeloma (MM) for patients aged inferior or equal to 65 years, achieving a response superior or equal to 50%
Lyon, France
myeloma (Must have received prior treatment for multiple myeloma) (A5481004)
and inferior or equal to 90% after an autologous hematopoietic stem cell (HSC) transplantation by a gene-identical or phenotype
multicenter
(VEL-FRA-2005-07)î
Phase II study of an alternative schedule of VELCADE/dexamethasone in the treatment of multiple myeloma (X05203)
Memphis, TN multicenter
Treatment of myeloma in patients <= 65 years old with response >= 50% and <= 90% after HSC autotransplant by allogenic
Lyon, France
Bortezomib (VELCADE) post allo for myeloma (2003-0751)
Houston, TX
transplant genoidentical or phenoidentical after reduced intensity conditioning (2005.385)
Phase II Study of bortezomib, cyclophosphamide, dexamethasone, and thalidomide in patients with newly diagnosed,
Seattle, WA multicenter
Phase II study to assess the safety, efficacy, and tolerability ofcombination therapy with VELCADE (bortezomib), adriamycin, and
Belfast, Ireland
previously untreated multiple myeloma (FHCRC-2123.00)
dexamethasone (PAD) as therapy for patients with relapsed or refractory multiple myeloma (VEL-EU-0061)
multicenter
Phase II study of bortezomib (VELCADE) and doxorubicin in relapsed or refractory multiple myeloma (VEL-03-081)
Madison, WI multicenter
II
This study plans to assess the response of PAD treatment to VAD or VAD-Like treatment in patients who have relapsed or refractory
Belfast, Ireland
Ph 2 bortezomib + doxorubicin for previously treated multiple myeloma (HO04402)
Madison, WI
myeloma (ICORG 05-01 PAD)
multicenter
Alternative schedule of VELCADE/dexamethasone for patients with multiple myeloma (ACORN ALJBMM0502)
multicenter
Bortezomib treatment before donor lymphocyte infusions (DLI) for myeloma patients relapsing or progressing after allogeneic
Milano, Italy
transplantation of hematopoietic cells (alloHSCT) (X05156)
multicenter
A study of the safety and efficacy of CNTO 328 and bortezomib to bortezomib alone in patients with relapsed or refractory multiple
multicenter
myeloma (CR012784)
High-dose treatment of previously untreated multiple myeloma patients aged <65 years (VEL-EU-0075)
Pavia, Italy
A comparative study to evaluate two different regimens of VELCADE in combination with dexamethasone, thalidomide
multicenter
A multicenter, open label study of bortezomib, thalidomide and dexamethasone as consolidation therapy in newly diagnosed
Torino, Italy
and cyclophosphamide (VDT vs VDTC) to treat newly diagnosed patients with multiple myeloma who are candidated
multiple myeloma patients who show at least a very good partial remission after autologous transplantation (VEL-03-096)
multicenter
for high-dose therapy and stem cell transplantation (26866138-MMY-2043)
Phase II trial evaluating the safety and efficacy of VELCADE as maintenance treatment in patients with multiple myeloma following
Tubingen, Germany
PHASE I/II
high dose melphalan treatment and autologous PBSCT in patients with minimal residual disease, patients in partial remission or
multicenter
with stable disease (i059-341-03)
Study of VELCADE and bone formation in patients with relapsed/refractory multiple myeloma (UARK 2004-22)
Little Rock, AR
VELCADE as maintenance treatment in patients with multiple myeloma following autologous peripheral blood stem cell
Würzberg, Germany
Phase I/II trial of autologous peripheral blood progenitor cell transplantation with VELCADE maintenance as treatment for
Los Angeles, CA
transplantation (PBSCT) (DSMM VIII)
multicenter
intermediate- and advanced-stage multiple myeloma (i34103-050)
PAD combination therapy followed by thal/dex for relapsed or refractory multiple myeloma (KMM55)
Incheon, South Korea
Phase I/II study of adjuvant bortezomib as maintenance therapy after autologous peripheral blood stem cell transplantation in patients
Los Angeles, CA
with Intermediate or advanced multiple myeloma (UCLA-0306106)
VTD followed by MPT maintenance as a first line treatment for the patients with MM who are non-transplant candidates (KMM52)
Incheon, South Korea
The combination of proteasome inhibition and farnesyltransferase inhibition as therapy for relapsed/refractory malignancies.
Atlanta, GA
Sequential VAD and VTD followed by HDT with ASCT and VELCADE maintenance for NDMM (KMM51)
Seoul, South Korea
A Phase I/II trial of bortezomib (VELCADE or PS-341) combined with R115777 (Zarnestra) (VEL-04-112)
A study of the safety and efficacy of CNTO 328 and bortezomib to bortezomib alone in patients with relapsed or refractory multiple
multicenter
Phase I/II open-label study of the safety and efficacy of bortezomib, lenalidomide, and dexamethasone combination therapy for patients Boston, MA multicenter
myeloma (CR012784)
with newly diagnosed multiple myeloma (X05188)
Bortezomib retreatment in multiple myeloma (CR010519)
multicenter
Phase I/II open-label study of the safety and efficacy of bortezomib, lenalidomide, +/ dexamethasone combination therapy for
Boston, MA multicenter
VELCADE (bortezomib), adriamycin dexamethasone (PAD) or vincristine adriamycin dexamethasone in second line treatment
multicenter
patients with relapsed or refractory multiple myeloma (X05189)
of multiple myeloma (CR011065)
Phase I/II study of the safety and efficacy of CCI-779 in combination with bortezomib in the treatment of subjects with relapsed and
Boston, MA
Bortezomib and high-dose melphalan at myeloma relapse (NMSG 16-07)
multicenter
relapsed/refractory multiple myeloma (X05224)
PHASE I/II
Bortezomib plus tacrolimus and methotrexate to prevent GVHD after mismatched allogeneic non-myeloablative blood stem cell
Boston, MA multicenter
I/II
transplantation (06-065)
Phase I/II trial of depsipeptide and VELCADE in patients with relapsed multiple myeloma (2006-VEL-AP-0019)
Melbourne, Australia
Bortezomib, lenalidomide and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma (06-150)
Boston, MA multicenter
A Phase I/II Trial of Romidepsin (depsipeptide) and bortezomib in patients with relapsed myeloma (06/34)
Melbourne, Australia
Combination CCI-779 (Temsirolimus) and bortezomib (VELCADE) in relapsed and/or relapsed/refractory multiple myeloma (06-365)
Boston, MA
I/II
Impact of VELCADE on bone turnover markers in multiple myeloma and non-hodgkin's lymphoma (2006-VEL-EU-0031)
Vejle, Denmark
multicenter
safety and efficacy study of GCS-100 in the treatment of multiple myeloma (PR-CS009)
Cambridge, MA
An open label, Phase I/II study of VELCADE in multiple myeloma patients undergoing reduced intensity conditioning allogeneic
multicenter
Sorafenib and bortezomib treatment for relapsed or refractory multiple myeloma patients (SCRI MM 14)
Bethesda, MD multicenter
transplantation (VEL-EU-0069)
Phase I/II study of VELCADE, dexamethasone, and Revlimid (lenalidomide) (VDR) versus VELCADE, dexamethasone,
Rochester, MN
PHASE I
cyclophosphamide, and Revlimid (VDCR) in subjects with previously untreated multiple myeloma ((Evolution) C05008)
Comparison of pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of bortezomib
Nantes, France
Trisenox, ascorbic Acid and bortezomib in patients with relapsed/refractory multiple myeloma (7365)
Durham, NC
I
in patients with multiple myeloma (BRD/05/9-B)
Phase I/II Study of doxorubicin HCl liposome, melphalan, and bortezomib in patients with relapsed or refractory Stage I-III
New York, NY multicenter
Safety study of LBH589 when given in combination with bortezomib in adult patients with multiple myeloma (CLBH589B2207)
multicenter
multiple myeloma (CPMC-AAAB6443)
Phase I/II study of hydroxychloroquine and bortezomib in patients with relapsed or refractory multiple myeloma (UPCC-01407)
Philadelphia, PA
Pilot (Pre-clinical) Testing of new therapies in a laboratory setting prior to testing on human subjects.
Bevacizumab and bortezomib in patients with advanced malignancy (2006-0764)
Houston, TX
Phase I Assess side effects of the treatment and determine a maximum tolerated dose.
A study of ATN-224 and bortezomib in patients with multiple myeloma (ATN-224-007)
multicenter
Phase I/II Study the safety, dosage levels, and response to a new treatment.
Phase II Assess anti-myeloma effects of treatment at the dose established in Phase I trial.
Phase I/II study of safety & efficacy of perifosine & bortezomib with or without dexamethasone for multiple myeloma patients
multicenter
Phase III Compare a newer treatment against current standard treatment.
(Perosifine 218)
Phase IV FDA approved, but further testing desired post-approval
PHASE I
Note: VELCADE®:bortezomib:PS-341
Safety study of dasatinib with bortezomib for multiple myeloma (CA180-181)
Orlando, FL
Phase I study of maintenance bortezomib in patients with multiple myeloma who have undergone an autologous peripheral
Detroit, MI multicenter
blood stem cell transplant (WSU-D-2957)
Phase I study of sorafenib and bortezomib in patients with advanced malignancies (MAYO-MC0511)
Rochester, MN
I
Safety study of LBH589 when given in combination with bortezomib in adult patients with multiple myeloma (CLBH589B2207)
Hackensack, NJ
multicenter
Phase I study of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms (MCV-MCC-6413)
Richmond, VA
To view a complete listing
multicenter
Study of oral suberoylanilide hydroxamic acid (SAHA) in combination with bortezomib in patients with advanced multiple myeloma
multicenter
of drugs and compounds
(2005_018)
in pre-clinical development,
PILOT
Determination of Epstein Barr Virus (EBV) load before and after treatment with tyrosine kinase or proteasome inhibitors: a pilot study
Chicago, IL
please visit the IMF website
PILOT (X05205)
at www.myeloma.org.
©2008 IMF International Myeloma Foundation