VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

Millennium Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Marginal Lymphoma

Follicular Lymphoma

B-Cell Lymphoma

Treatments

Drug: VELCADE and rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00085696

M34103-061

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Diagnosed or treated for a selected malignancies other than NHL within 5 years.
Active systemic infection requiring treatment
Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.