Trial intelligence / Profile preview

BDR in Previously Untreated Waldenstroms Macroglobulinemia

NCT00832234Phase 2

Key facts

Status
Completed
Start
Sep 2006
Primary completion
Jun 2010
Countries
1
Modality
Small Molecules, Modified Peptides
Conditions
Waldenström macroglobulinemia (WM)
01

Overview

Phase 2, open-label, single-arm trial of bortezomib in Waldenström macroglobulinemia (WM). Primary endpoint: Overall Response Rate at 2 years. Started Sep 2006; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • BDR Combination Therapy

    Bortezomib, Dexamethasone, and Rituximab combination.

03

Who it enrols

Previously untreated patients with a clinicopathological diagnosis of Waldenstroms macroglobulinemia who meet specific indications for treatment (e.g., symptomatic disease, cytopenias, or high M-protein) and have CD20 positive disease.

04

Endpoints

Primary

  • Overall Response Rate

Secondary

  • Time to Progression

  • Safety and Tolerability

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