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

This study has been completed.
Information provided by:
Centre National de Greffe de Moelle Osseuse Identifier:
First received: September 13, 2005
Last updated: January 26, 2009
Last verified: January 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 Intervention Phase
Multiple Myeloma Procedure: autologous PBSC transplant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Centre National de Greffe de Moelle Osseuse:

Primary Outcome Measures:
  • Overall survival (from randomistion) of the 2 groups at 5 years

Secondary Outcome Measures:
  • Event-free-survival

Estimated Enrollment: 202
Study Start Date: May 2003
Intervention Details:
    Procedure: autologous PBSC transplant
    optimal timining of a second autologous transplant

Ages Eligible for Study:   up to 61 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00207805

Centre National de Greffe de Moelle Osseuse
Tunis, Tunisia, 1006
Sponsors and Collaborators
Centre National de Greffe de Moelle Osseuse
Principal Investigator: abderrahman abdelkefi Centre National de Greffe de Moelle Osseuse
Principal Investigator: abderrahman abdelkefi, MD Centre National de Greffe de Moelle Osseuse
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00207805     History of Changes
Other Study ID Numbers: MM01
Study First Received: September 13, 2005
Last Updated: January 26, 2009

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases processed this record on August 18, 2017