NCT00312845

Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 676 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
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.
DRUG	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).

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2006-04-11
• Last updated: 2012-06-25
• Results posted: 2011-07-26

Locations

206 sites across 32 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Cyprus, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine, United Kingdom