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Sponsored by: |
Centre National de Greffe de Moelle Osseuse |
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Information provided by: | Centre National de Greffe de Moelle Osseuse |
ClinicalTrials.gov Identifier: | NCT00207805 |
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 | Intervention | Phase |
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Multiple Myeloma |
Procedure: optimal timining of a second autologous transplant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | up to 61 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Tunisia | |
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 |
Study ID Numbers: | MM01 |
Study First Received: | September 13, 2005 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00207805 |
Health Authority: | Tunisia: Ministère de la Santé Publique |
Immunoproliferative Disorders Hemorrhagic Disorders Multiple myeloma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |