Status:
COMPLETED
Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Millennium Pharmaceuticals, Inc.
Conditions:
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.
Detailed Description
* This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study. * Patients will receive 8 cycles of study treatm...
Eligibility Criteria
Inclusion
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM)
- No previous therapy for WM
- Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of greater than or equal to 2 times the upper limit of each institution's normal value
- CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment
- Karnofsky performance status \> 60
- Life expectancy \> 3 months
- AST (SGOT) \< 3 x ULN
- ALT (SGPT) \< 3 x ULN
- Total bilirubin \< 2 x ULN
- Calculated or measured creatinine clearance \> 30mL/minute
- Serum sodium \> 130 mmol/L
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
- Male subject agrees to use an acceptable method for contraception for the duration of the study
Exclusion
- Previous therapy for Waldenstrom's macroglobulinemia
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association 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 dexamethasone, boron or mannitol
- Pregnant or breast-feeding women
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00250926
Start Date
October 1 2005
End Date
February 1 2009
Last Update
April 8 2016
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215