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OpenTrials
Completed

NCT Number: NCT00207805

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous PBSC transplant

Procedure

optimal timining of a second autologous transplant

Primary outcomes

  1. Overall survival (from randomistion) of the 2 groups at 5 years

Secondary outcomes

  1. Event-free-survival

Sponsors and collaborators

Lead sponsor

Centre National de Greffe de Moelle Osseuse

Other Gov

Registry information

Important dates

Study start
2003
First posted
Sep 21, 2005
Registry last updated
Jan 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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