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

This study has been completed.
Sponsor:
Information provided by:
Centre National de Greffe de Moelle Osseuse
ClinicalTrials.gov Identifier:
NCT00207805
First received: September 13, 2005
Last updated: January 26, 2009
Last verified: January 2009
  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: autologous PBSC transplant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00207805     History of Changes
Other Study ID Numbers: MM01
Study First Received: September 13, 2005
Last Updated: January 26, 2009
Health Authority: Tunisia: Ministère de la Santé Publique

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014