Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

Completed · Phase 2

Conditions studied: Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma

In brief

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.

Key facts

Study ID

NCT00142129

Run by

Dana-Farber Cancer Institute

People needed

27

Starts

2003-12-01

Expected to finish

2007-06-01

Last updated by the study team

2011-06-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Greater than or equal to Grade 2 peripheral neuropathy
• Hypersensitivity to bortezomib, boron or mannitol
• Prior therapy with Velcade
• Pregnant or lactating women

Where it is running

• Dana-Farber Cancer Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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