Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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 cancer.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• 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 Criteria:

• Greater than or equal to Grade 2 peripheral neuropathy

• Hypersensitivity to bortezomib, boron or mannitol

• Prior therapy with Velcade

• Pregnant or lactating women