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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 is ongoing, but not recruiting participants.
Sponsored by: Centre National de Greffe de Moelle Osseuse
Information provided by: Centre National de Greffe de Moelle Osseuse
ClinicalTrials.gov Identifier: NCT00207805
  Purpose

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: optimal timining of a second autologous transplant
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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
  Eligibility

Ages Eligible for Study:   up to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207805

Locations
Tunisia
Centre National de Greffe de Moelle Osseuse
Tunis, Tunisia, 1006
Sponsors and Collaborators
Centre National de Greffe de Moelle Osseuse
Investigators
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 of Results:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009