Notícias e Destaques The Myeloma Matrix Part I (Phase II -> FDA Approved)

The Myeloma Matrix Part I (Phase II -> FDA Approved)
4.17.07

 

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.

Go to The Myeloma Matrix Part II (Phase I to Phase I/II) >>

 

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.
Ganite
(gallium nitrate)
Genta Inc. For treatment of cancer-related hypercalcemia.
Revlimid®
(CC-5013,
lenalidomide)
Celgene Corporation For use with dexamethasone for the treatment of myeloma patients who have had at least one prior therapy.
VELCADE® (bortezomib, PS-341) Millennium Pharmaceuticals For the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy..
EVEREST - VELCADE® Millennium Pharmaceuticals Assessing the efficacy, safety, and tolerability of retreatment with VELCADE®
Phase III
AMD-3100
Mozobil®
AnorMED Stem Cell mobilizer used with G-CSF prior to transplant. Trial now closed to enrollment; accrual complete.
Bondronat
(ibandronate)
Hoffmann-La Roche Randomized study of Bondronat versus Zometa for patients with malignant bone disease experiencing moderate to severe pain.
DOXIL®*
(doxorubicin liposome HCl injection)
Ortho Biotech Clinical trials using Doxil in place of Adriamycin in VAD; in combination with VELCADE and dex; and in combination with vincristine, dex, and thalidomide.
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.
Genasense®
(oblimersen, Bcl-2 antisense, G3139)
Genta, Inc. & Aventis Combined with dexamethasone for treatment of relapsed myeloma.
(Enrollment completed.)
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.)
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). .
Phase II
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.
Avastin™
(bevacizumab,
rhuMAb-VEGF)
Genentech Inc. For relapsed or refractory myeloma, with and without thalidomide.
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
CCI-779 National Cancer Institute Rapamycin analog for patients who have failed at least one prior therapy for myeloma.
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
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.
Erbitux,
cetuximab
Imclone Monoclonal antibody targeted to the EGFR. Trial is open to all stages of myeloma; patient must have had at least one prior treatment with disease progression.
Ethyol®
(
amifostine)
MedImmune, Inc. Cytoprotective agent to allow higher-dose melphalan in high-dose therapy with auto-transplant.
FR901228
(depsipeptide)
National Cancer Institute Novel chemotherapy agent for relapsed/refractory myeloma.
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.
HGS-ETR1
(TRM-1, mapatumumab)
Human Genome Sciences Monoclonal antibody to TRAIL-R1 used in combination with bortezomib in patients with relapsed or refractory myeloma.
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.
KRX-0401,
perifosine
Keryx Pharmaceuticals, Inc. Akt pathway inhibitor known as an alkylphosphocholine. Ph II safety and efficacy trial with perifosine alone and in combination with dexamethasone.
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.
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.
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
Revlimid®
(CC-5013,
lenalidomide)
Celgene In combination with Biaxin and dexamethasone for newly-diagnosed myeloma.
Rituxan
(rituximab)
NCI 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.
SCIO-469 Scios, Inc. Relapsed, refractory MM
Temodar®
(temozolomide)
Schering-Plough Corp. Combined with prednisone for relapsed or refractory myeloma. Study closed to enrollment.
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. Trials for frontline and maintenance therapy.
See complete list of VELCADE® trials.
Xcytrin (motexafin
gadolinium)
Pharmacyclics Relapsed and refractory myeloma.
XL999 Exelixis, Inc. Potent small molecule inhiitor of recepto tyrosine kinases FGF, VEGF, and PDGF being evaluated 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 indica