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The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma

NCT00207805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2009-01-27

No results posted yet for this study

Summary

Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard therapy in patients (\< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation. The probabilities of event-free-survival and overall survival were doubled with a double transplant. The benefits were greatest among patients who had not had a very good partial response to the first transplant.

The aim of this multicenter randomised trial in previously untreated patients with multiple myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection, patients are randomly assigned to receive two autologous PBSC transplants (arm A)or one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders.

Conditions

Interventions

PROCEDURE

autologous PBSC transplant

optimal timining of a second autologous transplant

Sponsors & Collaborators

  • Centre National de Greffe de Moelle Osseuse

    lead OTHER_GOV

Principal Investigators

  • abderrahman abdelkefi · Centre National de Greffe de Moelle Osseuse

  • abderrahman abdelkefi, MD · Centre National de Greffe de Moelle Osseuse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

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 NCT00207805 on ClinicalTrials.gov