Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00312845|
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : July 26, 2011
Last Update Posted : June 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: Bortezomib + Rituximab Drug: Rituximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||676 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2006|
|Primary Completion Date :||June 2010|
|Study Completion Date :||July 2010|
|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).
- 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. ]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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312845
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|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|