The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00207805|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 27, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: autologous PBSC transplant||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2003|
Procedure: autologous PBSC transplant
- Overall survival (from randomistion) of the 2 groups at 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207805
|Centre National de Greffe de Moelle Osseuse|
|Tunis, Tunisia, 1006|
|Principal Investigator:||abderrahman abdelkefi||Centre National de Greffe de Moelle Osseuse|
|Principal Investigator:||abderrahman abdelkefi, MD||Centre National de Greffe de Moelle Osseuse|