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

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

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.

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.