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

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.