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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207805
• Other study ID #: MM01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 26, 2009
• Start date: May 2003

Study information

• Verified date: January 2009
• Source: Centre National de Greffe de Moelle Osseuse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministère de la Santé Publique
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 61 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• autologous PBSC transplant
optimal timining of a second autologous transplant

Locations

Country	Name	City	State
Tunisia	Centre National de Greffe de Moelle Osseuse	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Centre National de Greffe de Moelle Osseuse

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Abdelkefi A, Torjman L, Ben Romdhane N, Ladeb S, El Omri H, Ben Othman T, Elloumi M, Bellaj H, Lakhal A, Jeddi R, Aissaouï L, Saad A, Hsaïri M, Boukef K, Dellagi K, Ben Abdeladhim A. First-line thalidomide-dexamethasone therapy in preparation for autologo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (from randomistion) of the 2 groups at 5 years
Secondary	Event-free-survival