VELCADE/Melphalan/Prednisone Versus Melphalan/Prednisone in Patients With Previously Untreated Multiple Myeloma
The primary reason for this study is to determine whether the addition of VELCADE (bortezomib) for injection to standard melphalan/prednisone (MP) therapy improves the time to disease progression (TTP) in subjects with previously untreated multiple myeloma.
Millennium Pharmaceuticals, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Randomized Study of VELCADE/Melphalan/Prednisone Versus Melphalan/Prednisone in Subjects With Previously Untreated Multiple Myeloma|
- Time to progression [ Designated as safety issue: No ]
- Progression-free survival, overall response rate, overall survival, time to first response, duration of response, CR rate, and patient reported outcomes as assessed using the EORTC QLQ-C30, FACIT-F and EQ-5D instruments. [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
|United States, Indiana|
|Investigative Clinical Research of Indiana, LLC|
|Indianapolis, Indiana, United States, 46254|
|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|