Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.
Drug: Bortezomib + Rituximab
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma|
- Progression Free Survival [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ] [ Designated as safety issue: No ]Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
- Overall Response Rate [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ] [ Designated as safety issue: No ]Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.
|Study Start Date:||March 2006|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
|Experimental: Bortezomib + Rituximab||
Drug: Bortezomib + Rituximab
VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.
|Active Comparator: Rituximab||
rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312845
Show 206 Study Locations
|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|