NCT00207805

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (planned)
• Sponsor: Centre National de Greffe de Moelle Osseuse · Other Government
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

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

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	autologous PBSC transplant	optimal timining of a second autologous transplant

Timeline

• Start date: 2003-05-01
• First posted: 2005-09-21
• Last updated: 2009-01-27

Locations

1 site across 1 country: Tunisia