Multiple Myeloma Clinical Trial
Official title:
A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."
This is a phase III, multicenter, prospective with a clinical benefit, open-label and
randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide
Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an
Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly
Diagnosed Multiple Myeloma.
Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4
consecutive 21 day cycles of an induction treatment with either VTD or VCD.
The patient population will consist of adult men and women who have a confirmed diagnosis of
Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the
patients consulting in an investigating centre's haematology service for newly diagnosed,
symptomatic, untreated multiple myeloma.
in each treatment arm there will be :
1. Induction therapy : 4 cycles of VTD (21 days)or VCD
2. Systematic stem cell harvest after cycle 3
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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