Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Millennium Pharmaceuticals, Inc.
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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