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MYELOMA
Genasense and Dexamethasone
GMY302: a randomized, phase-III study of dexamethasone with or without Genasense (Bcl-2 antisense oligonucleotide) in patients with relapsed or refractory multiple myeloma. Resistance to anticancer therapy is sometimes associated with the presence in cancer cells of a protein called Bcl-2. Genasense is a drug that turns off the production of the Bcl-2 protein, thereby increasing a tumor cell's sensitivity to therapy and leading to programmed cell death (apoptosis) a natural process by which the body rids itself of unwanted cells.
Sponsor: Genta Incorporated
Principal Investigator: Dr. Ruben Niesvizky
0101-569
Thalidomide, Dexamethasone, Biaxin
A randomized trial comparing low-dose thalidomide and dexamethasone versus dexamethasone, with or without the antibiotic Biaxin, for the treatment of newly diagnosed multiple myeloma. The study follows upon an earlier study at Weill Cornell that obtained very encouraging results from low-dose thalidomide, dexamethasone and Biaxin in combination.
Sponsor: Celgene Corporation
Principal Investigator: Dr. Ruben Niesvizky
0101-570
Molecular pathogenesis
Investigation of the molecular pathogenesis of multiple myeloma through laboratory studies of patientsí bone marrow and blood.
Principal Investigator: Dr. Roger Pearse
1000-422
Dexamethasone Versus PS-341 for Multiple Myeloma
M34101-039: This international, randomized, open-label study compares the efficacy of PS-341 to that of high-dose dexamethasone in patients with refractory multiple myeloma. Dexamethasone, a steroid similar to but more powerful than hydrocortisone, is commonly used for treatment of multiple myeloma, while PS-341 is a new drug that has yielded encouraging results with minimal toxicity in patients refractory to other treatments. PS-341 blocks the degradation of intracellular proteins so as to interfere with a transcription factor that drives cell overproliferation in this disease.
Sponsor: Millennium Pharmaceuticals
Principal Investigator: Dr. Michael Schuster
0702-338
PS-341 for Multiple Myeloma
M34101-040: This international, open-label, non-comparative study of PS-341 is open to patients who 1) have already received four or more previous regimens or 2) were randomized to receive dexamethasone in the comparative trial M34101-39 (see above) and saw their condition worsen.
Sponsor: Millennium Pharmaceuticals
Principal Investigator: Dr. Ruben Niesvizky
0302-186
Extended Treatment with PS-341
A phase-II, open label, extension study to provide PS-341 to myeloma patients who previously participated in a PS-341 clinical study and may benefit from retreatment or from continuation of PS-341 therapy.
Principal Investigator: Dr. Ruben Niesvizky
0602-311
Chemotherapy Plus Immunotherapy for Waldenstromís Macroglobulinemia
A phase-II study of fludarabine induction followed by high-dose cyclophosphamide consolidation and administration of the monoclonal antibody Rituxan for the treatment of Waldenstrom's Macroglobulinemia.
Principal Investigator: Dr. Ruben Niesvizky
1000-424
Targeted Radiotherapy
A phase-I dosimetry and dose-escalation study of LymphoRad-131, a new agent consisting of a monoclonal antibody fused to a radioactive isotype of iodine. The drug targets a broad range of B-cell tumors, as well as receptors found on multiple-myeloma cells, delivering low doses of radiation that cause cell death.
Sponsor: Human Genome Sciences
Principal Investigator: Dr. Ruben Niesvizky
0902-467
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