Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia (WM)

Inclusion Criteria:

18 years of age or older
Patients with previously untreated WM and those who have received prior therapy are eligible
Must have received prior therapy for their WM and have relapsed or refractory WM.
CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment.
Measurable disease
ECOG Performance Status 0,1, or 2
Total bilirubin < 2.0 mg/dl
AST < 3 x ULN
Life expectancy of greater than 12 weeks

Exclusion Criteria:

Uncontrolled infection
Other active malignancies
Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks, prior to registration.
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
Known to be HIV positive or HEP B positive
Radiation therapy less than 2 weeks prior to registration
Grade 2 or greater peripheral neuropathy
Myocardial infarction within 6 months rior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Hypersensitivity to bortezomib, boron, or mannitol
Pregnant or breast feeding women
Other investigational drugs within 14 days of enrollment
Serious medical or psychiatric illness likely to interfere with participation