Trial intelligence / Profile preview

Bortezomib, Lenalidomide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT00378209Phase 2

Key facts

Status
Completed
Start
Aug 2006
Primary completion
Oct 2012
Countries
1
Sponsor
Dana-Farber Cancer Institute
Modality
Modified Peptides, Orthosteric Ligands
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, open-label, single-arm trial of bortezomib, lenalidomide and dexamethasone in multiple myeloma (MM), sponsored by Dana-Farber Cancer Institute. Primary endpoint: Proportion of Patients Alive and Without Progressive Disease at 6 months. Started Aug 2006; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • lenalidomide, dexamethasone, bortezomib combination

    Combination of Bortezomib, Lenalidomide, and Dexamethasone.

03

Who it enrols

Patients with relapsed or relapsed/refractory multiple myeloma (1-3 prior lines) with adequate organ function and no severe neuropathy.

04

Endpoints

Primary

  • Proportion of Patients Alive and Without Progressive Disease

Secondary

  • Objective Response Rate

  • Duration of Response

  • Progression Free Survival

  • Overall Survival

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