Status:
COMPLETED
Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 fo...
Detailed Description
* Participants will receive 6 cycles of the study treatment with bortezomib and rituximab. Each cycle is 28 days long (4 weeks). * Participants will receive Rituximab intravenously once a week for the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00422799
Start Date
August 30 2006
End Date
October 9 2015
Last Update
October 27 2020
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115