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

Phase 3

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00207805
• Lead Sponsor: Centre National de Greffe de Moelle Osseuse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-26
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• patients less than 61 years of age
• Durie Salmon stage II or III
• written and informed consent

Exclusion Criteria

• Prior treatment for myeloma
• ECOG performance score of 4
• Positive HIV test
• Chronic respiratory disease (DLco < 60%)
• Systolic ejection fraction < 50%
• Pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival (from randomistion) of the 2 groups at 5 years

Secondary Outcome Measures

Name	Time	Method
Event-free-survival

Trial Locations

Locations (1)

Centre National de Greffe de Moelle Osseuse; 🇹🇳 Tunis, Tunisia