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The Myeloma Matrix Part I (Phase II -> FDA Approved)
11.12.09

IMF Myeloma Matrix - Phase II- FDA Approved

The IMF is committed to providing a total overview of the "future" as well as the current state of myeloma treatments. The printed version of the Myeloma Matrix provides updated information about drugs beginning with pre-clinical developments, tracks drugs as they proceed through Phases I – III of clinical trials, and provides information on trials that are being conducted by NCI-sponsored cooperative groups as well as other myeloma study groups. Call the toll-free hotline (800) 452-2873 for your printed copy.

  • Pre-clinical—Testing of new therapies in a laboratory setting prior to testing on human subjects.
  • Phase I—Assess side effects of the treatment and determine a maximum tolerated dose.
  • Phase II—Assess anti-myeloma effects of treatment at the dose established in Phase I trial.
  • Phase III—Compare a newer treatment against current standard treatment.
PHASE
BRAND NAME
(OTHER NAME)
COMPANY
(SPONSOR)
INDICATION
Recently FDA Approved
Aranesp™ (darbepoetin alfa, NESP)
Amgen
Anemia caused by kidney disease or some forms of chemotherapy.
DOXIL®*
(doxorubicin liposome HCl injection)
In combination with bortezomib for patients who have not previously received bortezomib and have received at least one prior therapy.
Ganite
(gallium nitrate)
Genta Inc.
For treatment of cancer-related hypercalcemia.
Mozobil
(plerixafor
AMD 3100)
Genzyme Stem cell mobilizer used with G-CSF prior to transplant.
Revlimid®
(CC-5013,
lenalidomide)
Celgene Corporation
For use with dexamethasone for the treatment of myeloma patients who have had at least one prior therapy.
Thalomid
(thalidomide)
Celgene Corporation Indicated for the treatment of patients with newly diagnosed multiple myeloma
VELCADE® (bortezomib, PS-341)
Millennium Pharmaceuticals
In June 2008, VELCADE®’s approval was expanded to include previously untreated myeloma patients.
Phase III
DOXIL®/CAELYX and VELCADE or VELCADE Monotherapy
Ortho Biotech
For patients whose disease has progressed after an initial response to at least 1 line of prior therapy or was refractory to initial treatment.
ExAblate
(MRI-guided focused ultrasound surgery)
InSightec Inc. Randomized, placebo-controlled study for the palliation of pain in patients with bone metastases or myeloma who are not candidates for radiation therapy.
perifosine
(KRX-0401)
Keryx Biopharmaceuticals Randomized, double-blind, placebo-controlled study to assess the efficacy and safety of perifosine added to the combination of bortezomib and dexamethasone in mm patients previously treated with bortezomib.
Revlimid®
(CC-5013,
lenalidomide)
Celgene Corporation A multicentre, randomised, double-blind, placebo-controlled, 3-arm parallel group study to determine the efficacy and safety of Revlimid in combination with melphalan and prednisone versus placebo plus melphalan and prednisone in subjects with newly diagnosed multiple myeloma who are 65 years or older. (Note: This study is being conducted outside the US.)
tanespimycin
(KOS-953, 17-AAG)
Kosan Biosciences Open-label trial for MM patients in first relapse with tanespimycin plus bortezomib (Velcade) compared to bortezomib alone.
Thalomid®* (thalidomide) Celgene Corporation and the NCI Randomized study of thalidomide + prednisone as maintenance therapy after auto-transplant;  randomized study of combination chemotherapy with or without thalidomide (Europe only). .
Zolinza
(vorinostat
MK0683)
Merck An international, multicenter, randomized, double-blind study of vorinostat or placebo in combination with bortezomib in patients with mm
Phase II/III
MAGE-A3 and
NY-ESO-1 (peptide
vaccination)
University of Arkansa and Celgene Corp. Subcutaneous peptide vaccination in combination with DT-PACE and autotransplant.
tanespimycin
(KOS-953)
Bristol-Myers Squibb Randomized, open-label clinical trial of tanespimycin (KOS-953) plus bortezomib comparing three doses of tanespimycin in patients with relapsed-refractory multiple myeloma.

Phase II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Phase II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Phase II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Phase II

 

 

 

 

 

 

 

Phase II

ACE-011
Celgene Corporation
and
Acceleron Pharma
Protein based on activin receptor IIA that works by both inhibiting bone loss and stimulating bone formation.
AMG162
(denosumab,
osteoprotegerin, OPG)
Amgen
For treatment of patients with bone metastases due to advanced solid tumors or multiple myeloma and for the treatment of patients with relapsed or plateau-phase multiple myeloma.
Aplidin®
PharmaMar, SA
For relapsed or refractory myeloma
AP23573
Ariad Pharmaceuticals
Rapamycin analog for refractory or recurrent malignancy, including myeloma and lymphoma.
Atiprimod
Calisto
Pharmaceuticals
For patients with refractory multiple myeloma who have failed two or more prior therapies.
ATN-224
Attenuon, LLC
Given in combination with Velcade to patients who are relapsed from or refractory to Velcade. .
Avastin™
(bevacizumab,
rhuMAb-VEGF)
Genentech Inc.
Given in combination with Velcade to patients with relapsed/refractory mm.
azacitidine (Vidaza®)
Investigator initiated
Drug previously approved in US for MDS being used in clinical trial for rel/ref mm in Melbourne, Australia.
Bexxar
(Iodine I 131 tositumomab)
GlaxoSmithKline,
U of Michigan
Radioactive antibody to CD20-expressing cells for patients with newly diagnosed or relapsed multiple myeloma.
Campath-1H
(alemtuzumab,
monoclonal
antibody CD52)
NCI and Fred Hutchinson Cancer Research Institute
Used before allo transplant to prevent GVHD
carfilzomib (PR-171)
Proteolix
Study of carfilzomib in relapsed and refractory mm at St. Vincent’s Hospital in NY.
CC4047 (formerly “Actimid”)
(pomalidomide)
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 ass't, Melanie Thompson, at 507-266-0733.
For patients with relapsed disease who have had 3 or fewer previous regimens.
Celebrex
(celecoxib)
National Cancer Institute
Prevention study for patients with MGUS or smoldering myeloma.
CG53135-05
CuraGen
For treatment of oral mucositis in patients undergoing autologous stem cell transplant
CNTO 328
Centocor
Given in combination with Velcade to patients with relapsed/refractory mm.
CTY997
Cytopia Limited
Prospective, single-arm, open-label trial of a vascular-disrupting agent in the treatment of relapsed/refractory mm.
dasatinib (Sprycel™; BMS-354825)
Bristol-Myers Squibb
BCR/ABL and Src tyrosine kinase inhibitor for treatment of relapsed or plateau phase MM.
Dendritic Cell
Vaccine
Arkansas Cancer Research Center
Autologous dendritic cells for high-risk mutiple myeloma.
DLI (donor
lymphocyte
infusion)
National Cancer Institute
For relapse following allo transplant.
eltrombopag
(SB-497115; "115")
GlaxoSmithKline
Small-molecule drug that mimics the activity of thrombopoietin (TPO) to promote growth and production of platelets.
enzastaurin
Eli Lilly
A Study for Patients Who Have Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma
Site info: Dana-Farber Cancer Institute, Boston, MA, Dr. Irene Ghobrial, PI, 617-632-4198; Nantes, France and Paris, France.
Erbitux,
cetuximab
Eli Lilly
EMMA-1 (Erbitux for Multiple Myeloma); cetuximab +/- dex for patients with refractory mm stage II or III or relapsed disease after at least one line of treatment.
Site Info: University of Cologne, Germany
Ethyol®
(amifostine)
MedImmune, Inc.
Cytoprotective agent to allow higher-dose melphalan in high-dose therapy with auto-transplant.
Gallium
Maltolate
Titan Pharmaceuticals
Treatment of myeloma-related bone disease.
Genasense
(oblimersen,
Bcl-2
antisense,
G3139)
Genta, Inc.
Trials combining Genasense with other regimens in relapse setting.
GM-CSF
(Leukine)
US Oncology
Maintenance therapy post auto transplant for MM
GVAX
Cell Genesys, Inc.
Newly diagnosed myeloma patients undergoing transplant.

INCB018424
(JAK2-inhibitor)

Incyte Corporation
Small molecule Janus kinase inhibitor for patients with rel/ref mm.
IPH 2101 Innate Pharma Multi-center, open-label trial designed to evaluate IPH2101 as a single agent in patients with stable multiple myeloma after induction therapy.
ITF2357
Italfarmaco
Histone deacetylase inhibitor given as monotherapy to patients with relapsed or progressive mm.
Kineret™  
(anakinra)   
Amgen  
Mayo (Rochester) study of IL-1beta antagonist for smoldering/indolent MM
KIR-Ligand
Mismatched
Haplo-Identical
Natural Killer
Cells
Arkansas Cancer Research Center
For relapse after single or tandem transplant and for high-risk multiple meloma.
KLH vaccine
(keyhole limpet
hemocyanin)
National Cancer Institute
Low or intermediate risk myeloma patients undergoing autotransplant.
LBH589
Novartis
HDAC inhibitor for patients with relapsed/refractory myeloma who have received at least two prior lines of therapy and whose disease has progressed on the latest therapy.
mapatumumab
(HGS-ETR1; TRM-1; HGS1012)
Human Genome Sciences
Monoclonal antibody to TRAIL-R1 used in combination with bortezomib in patients with relapsed or refractory myeloma.
Neotrofin®
(leteprinim
potassium)
NeoTherapeutics
For treatment of chemotherapy-induced peripheral neuropathy. (Enrollment completed.)
Neulasta®
(pegfilgrastim,
pegylated
G-CSF)
Amgen
Pegylated G-CSF (filgrastim) for stem cell mobilization prior to harvest.
Nexavar®
(BAY 43-9006, sorafenib, sorafenib tosylate)
Bayer and Onyx Pharmaceuticals
Oral therapy targeted to receptor tyronsine kinases involved with both tumor cell proliferation and angiogenesis; for patients with relapsed or refractory myeloma.
O-6-benzyl-
guanine
National Cancer Institute and Pacific Pharmaceuticals
Novel chemotherapy for treatment of relapsed myeloma.
Panzem™
(2-meth-
oxyestradiol,
2ME2)
EntreMed, Inc.
Antiangiogenesis agent for treatment of relapsing myeloma.

PD 0332991

Pfizer

In combination with Velcade and dexamethasone in patients who have received at least one prior treatment for mm.

perifosine
(KRX-0401)
Keryx Pharmaceuticals, Inc.
Akt pathway inhibitor known as an alkylphosphocholine. Ph II safety and efficacy trial with perifosine alone and in combination with dexamethasone.
PI-88
Progen Industries Limited
Phase II trial of VEGF inhibitor completed in Australia; early planning stages in US.
Prochymal
Osiris Therapeutics
For treatment of GVHD (graft versus host disease) following allo transplant.
Proleukin®
(IL-2,
Interleukin-2)
National Cancer Institute and Chiron
For advanced myeloma as part of auto or syngeneic transplant.
PTK787
Novartis and Schering, AG
Novel oral angiogenesis inhibitor as post-transplant maintenance following high-dose therapy and autologous SCT.
PXD101
CuraGen and TopoTarget A/S
Small molecule histone deacetylase inhibitor for MM patients who have failed at least 2 prior treatment regimens.
Quadramet®
(EDTMP,
samarium-153
ethylene
diamine
tetramethylene
phosphonate
Samarium)
Mayo Clinic, Rochester, MN
In combination with standard high-dose chemotherapy for patients undergoing stem cell transplant.
RAD001
(everolimus)
Novartis
mTOR (mammalian target of Rapamycin) inhibitor for patients with relapsed/refractory mm.
resveratrol
(SRT501)
GlaxoSmithKline Open-label clinical study to assess the safety and activity of SRT501 with or without concurrent bortezomib administration, when administered once daily in 21-day cycles, in male and female subjects with multiple myeloma.
Revlimid®
(CC-5013,
lenalidomide)
Celgene
Various trials in combination with other agents, including bortezomib, thalidomide, cyclophosphamide and dexamethasone for relapsed/refractory mm.

Rituxan
(rituximab)

Biogen Idec &
Genentech

High-dose cyclophosphamide in combination with rituximab in patients with primary refractory, high-risk, or relapsed myeloma; also being studied for the treatment of peripheral neuropathy in patients with MGUS.

romidepsin
(depsipeptide, FR901228)
Gloucester Pharmaceuticals
Novel chemotherapy agent for relapsed/refractory myeloma.
SCH 727965
Schering-Plough Cyclin-dependent kinase inhibitor.
SCIO-469
Scios, Inc.
Relapsed, refractory MM
sorafenib
See Phase II Nexavar.
sunitinib (sunitinib malate, Sutent®)
Pfizer
Multicenter efficacy trial of oral agent previously approved for GIST and kidney cancer.
Thalomid®*
(thalidomide)
Celgene Corporation
Used with dexamethasone as induction therapy before, and with prednisone as maintenance therapy after, high-dose therapy with stem cell transplant.
VEGF Trap
(NSC 724770)
Regeneron
Open-label safety and efficacy study for patients with relapsed or refractory multiple myeloma.
VELCADE®
(bortezomib,
PS-341, LDP-
341,
MLN-341)
Millennium Pharmaceuticals, Inc.
In combination with various drugs for frontline therapy, relapsed/refractory disease, and maintenance.
See complete list of Phase II VELCADE® trials.
Xcytrin (motexafin
gadolinium)
Pharmacyclics
Relapsed and refractory myeloma.
XL999
Exelixis, Inc.
Potent small molecule inhibitor of recepto tyrosine kinases FGF, VEGF, and PDGF being evaluated in patients with relapsed or refractory mm.
ZIO-101
ZIOPHARM, Inc.
Multi-center trial of small-molecule organic arsenic.
Zolinza
(vorinostat
MK0683)
Merck An international,. multicenter, open-label study of vorinostat in combination with bortezomib in patients with relapsed or refractory mm.
* Approved for prescription by the US Food and Drug Administration prior to January 2001, but are not specifically indicated for the treatment of multiple myeloma.

** Approved for prescription by the US Food and Drug Administration, but are not specifically indicated for the treatment of multiple myeloma. At this time, none of these products are in common use for management of myeloma.

.The Myeloma Matrix is brought to you in part
by a grant from
Celgene Corporation
© 2009 The International Myeloma Foundation

 
PDF of the Myeloma Matrix (Note: There may have been changes to the online Matrix since the printed document was published.)

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This page last modified on ( 11.12.09 )
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