NCT00636792

A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	VELCADE	VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.
DRUG	Bendamustine	Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle
DRUG	Rituximab	Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-03-14
• Last updated: 2012-01-13
• Results posted: 2011-06-22

Locations

2 sites across 1 country: United States