A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039|
|Study Start Date:||April 2002|
|Study Completion Date:||July 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.
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