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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207805
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 27, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: autologous PBSC transplant Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Intervention Details:
    Procedure: autologous PBSC transplant
    optimal timining of a second autologous transplant

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

Secondary Outcome Measures :
  1. Event-free-survival

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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

Information from the National Library of Medicine

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 identifier (NCT number): 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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00207805     History of Changes
Other Study ID Numbers: MM01
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 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