A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

Millennium Pharmaceuticals, Inc.13 sites in 1 country66 target enrollmentMay 2004

ConditionsB-Cell Lymphoma Follicular Lymphoma Marginal Lymphoma

DrugsVELCADE and rituximab

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: B-Cell Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 66
Locations: 13
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

April 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•Male or female subject 18 years or older
•Diagnosis of B-cell lymphoma (CD20+) of
•follicular lymphoma (grades 1, 2, and 3) or
•marginal zone lymphoma (extranodal, nodal, and splenic)
•Documented relapse or progression following prior anti-neoplastic treatment.
•At least 1 measurable lymph node mass that is \>1.5 cm.
•No active CNS lymphoma
•Voluntary consent

Exclusion Criteria

•Previous treatment with VELCADE
•Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
•Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
•Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug.
•Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug.
•Radiation therapy within 3 weeks before the first dose of study drug.
•Major surgery within 2 weeks before the first dose of study drug.
•Peripheral neuropathy or neuropathic pain
•History of allergic reaction attributable to compounds containing boron or mannitol
•Known anaphylaxis or hypersensitivity to any component of rituximab