Trial intelligence / Profile preview

Sequential VAD and VTD Induction in MM

NCT00378755Phase 2

Key facts

Status
Unknown
Start
Mar 2006
Countries
1
Modality
Small Molecules, Modified Peptides
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, open-label, single-arm trial of bortezomib in multiple myeloma (MM). Primary endpoint: Response Rate of Sequential VAD and VTD Induction. Status: unknown.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Sequential VAD/VTD + ASCT + Maintenance

    Sequential induction with VAD and VTD, followed by ASCT and Bortezomib maintenance.

03

Who it enrols

Newly diagnosed MM patients (Stage II-III) under 65 years old with adequate organ function and no severe neuropathy or cardiovascular disease.

04

Endpoints

Primary

  • Response Rate of Sequential VAD and VTD Induction

Secondary

  • Progression Free Survival

  • Duration of Response

  • Overall Survival

  • Toxicities

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