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Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia

NCT00492050 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-11

Study results available
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Summary

The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given with rituximab can help to control WM. This drug combination will allow researchers to collect your stem cells in case it is possible to transplant the stem cells as treatment if your WM gets worse. Researchers will also look at the safety and tolerability of this drug combination followed by treatment with other drug combinations.

Conditions

  • Waldenstrom's Macroglobulinemia

Interventions

DRUG

Bortezomib

1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22.

DRUG

Rituximab

375 mg/m\^2 IV on Day 8 and 22.

DRUG

Valacyclovir

500 mg orally daily (or acyclovir 200 mg orally twice daily)

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sheeba Thomas, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-02
Primary Completion
2021-02-28
Completion
2026-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00492050 on ClinicalTrials.gov