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

• Status: Completed
• Trial end date: 2015-10-09
• Target enrollment: 0
• Participant gender: All

Summary

In this study, we are trying to find out if the combination of these two drugs is effective in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's macroglobulinemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Rituximab

Criteria

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