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

NCT ID: NCT00207805

Last Updated: 2009-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous PBSC transplant

optimal timining of a second autologous transplant

Intervention Type: PROCEDURE

Eligibility 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

• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre National de Greffe de Moelle Osseuse

OTHER_GOV

Sponsor Role: lead

Principal Investigators

abderrahman abdelkefi

Role: PRINCIPAL_INVESTIGATOR

Centre National de Greffe de Moelle Osseuse

abderrahman abdelkefi, MD

Role: PRINCIPAL_INVESTIGATOR

Centre National de Greffe de Moelle Osseuse

Locations

Centre National de Greffe de Moelle Osseuse

Tunis, , Tunisia

Countries

Tunisia

References

Abdelkefi A, Torjman L, Ben Romdhane N, Ladeb S, El Omri H, Ben Othman T, Elloumi M, Bellaj H, Lakhal A, Jeddi R, Aissaoui L, Saad A, Hsairi M, Boukef K, Dellagi K, Ben Abdeladhim A. First-line thalidomide-dexamethasone therapy in preparation for autologous stem cell transplantation in young patients (<61 years) with symptomatic multiple myeloma. Bone Marrow Transplant. 2005 Aug;36(3):193-8. doi: 10.1038/sj.bmt.1705050.

Reference Type: RESULT

PMID: 15968290 (View on PubMed)

Abdelkefi A, Ladeb S, Torjman L, Othman TB, Lakhal A, Romdhane NB, Omri HE, Elloumi M, Belaaj H, Jeddi R, Aissaoui L, Ksouri H, Hassen AB, Msadek F, Saad A, Hsairi M, Boukef K, Amouri A, Louzir H, Dellagi K, Abdeladhim AB; Tunisian Multiple Myeloma Study Group. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial. Blood. 2008 Feb 15;111(4):1805-10. doi: 10.1182/blood-2007-07-101212. Epub 2007 Sep 17.

Reference Type: DERIVED

PMID: 17875806 (View on PubMed)

Other Identifiers

MM01

Identifier Type: -

Identifier Source: org_study_id