Clinical trial NCT00207805: The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Centre National de Greffe de Moelle Osseuse
Sponsor class: OTHER_GOV
First posted: 2005-09-21
Enrollment: 202
Sex: ALL
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival (from randomistion) of the 2 groups at 5 years
Secondary outcomes:
measure: Event-free-survival
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Centre National de Greffe de Moelle Osseuse
Study officials:
affiliation: Centre National de Greffe de Moelle Osseuse
name: abderrahman abdelkefi
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre National de Greffe de Moelle Osseuse
name: abderrahman abdelkefi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.