Multiple Myeloma Clinical Trial
Official title:
A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long their responses last, whether they live longer, and what side effects are caused by each combination.
The trial will compare complete response rates and duration of complete response of patients receiving at least 6 to 8 cycles of therapy with lenalidomide plus low-dose dexamethasone and reached plateau of best response (Arm B) versus patients receiving 4 cycles of therapy with lenalidomide plus low-dose dexamethasone followed by autologous peripheral blood stem cell transplant conditioned with 200 mg/m2 melphalan (Arm A). Provide a brief abstract summarizing the specific aims, experimental design, methods and subject population. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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