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Phase III Study of Three Treatment Regimens in Patients with Previously Untreated Multiple Myeloma Who Are Not Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation
[Protocol 08-018]
- Full Title :
- RANDOMIZED PHASE 3B STUDY OF THREE TREATMENT REGIMENS IN SUBJECTS WITH PREVIOUSLY UNTREATED MULTIPLE MYELOMA WHO ARE NOT CONSIDERED CANDIDATES FOR HIGH-DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION: VELCADE (BORTEZOMIB), THALIDOMIDE, AND DEXAMETHASONE (VTD) VERSUS VELCADE AND DEXAMETHASONE (VD) VERSUS VELCADE, MELPHALAN, AND PREDNISONE (VMP)
- Purpose :
Bortezomib (Velcade®), melphalan, thalidomide, dexamethasone, and prednisone are drugs used in the treatment of multiple myeloma. The purpose of this study is to compare the effectiveness of three different combinations of these drugs in patients who are newly diagnosed with multiple myeloma who are experiencing symptoms, have not yet had therapy, and are not considered candidates for high-dose chemotherapy with stem cell transplantation.
Patients will be randomly assigned to receive one of these treatment regimens:
- bortezomib plus dexamethasone
- bortezomib, dexamethasone, and thalidomide
- bortezomib, melphalan, and prednisone
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of symptomatic multiple myeloma that has not yet been treated with any therapy.
- Patients may not be candidates for high-dose chemotherapy with autologous stem cell transplantation.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Hani Hassoun at 212-639-3228.
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