Status:
COMPLETED
Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Waldenstrom's Macroglobulinemia
Lymphoplasmacytic Lymphoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the...
Detailed Description
* Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8 and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of treatment. The treatment cycl...
Eligibility Criteria
Inclusion
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy
- Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of \>2 times ULN
- Karnofsky performance status of \>60
- Life expectancy of \> 3 months
- Baseline platelet count \>50,000,000,000/L and ANC of 750,000,000/L
- AST and ALT \< 3 x ULN
- Total bilirubin \< 2 x ULN
- Calculated or measured creatinine clearance \> 30mL/minute
- Serum sodium \> 130 mmol/L
Exclusion
- Greater than or equal to Grade 2 peripheral neuropathy
- Hypersensitivity to bortezomib, boron or mannitol
- Prior therapy with Velcade
- Pregnant or lactating women
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00142129
Start Date
December 1 2003
End Date
June 1 2007
Last Update
June 27 2011
Active Locations (2)
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1
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215