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MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation

NCT00256776 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2021-10-18

Study results available
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Summary

This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation.

Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.

Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.

Conditions

Interventions

DRUG

Velcade (Bortezomib)

DRUG

Thalidomide

DRUG

Dexamethasone

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2013-12-31
Completion
2015-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT00256776 on ClinicalTrials.gov