Overview

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