Conditions: Non-Hodgkin's Lymphoma
Keywords: B-cell Non-Hodgkin's Lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 676
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Bortezomib + Rituximab intervention 2: Rituximab
Intervention descriptions: intervention 1: 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. intervention 2: 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).

Protocol document: