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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
autologous PBSC transplant
Sponsored by
Centre National de Greffe de Moelle Osseuse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

undefined - 61 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre National de Greffe de Moelle Osseuse

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Event-free-survival

Full Information

First Posted
September 13, 2005
Last Updated
January 26, 2009
Sponsor
Centre National de Greffe de Moelle Osseuse
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1. Study Identification

Unique Protocol Identification Number
NCT00207805
Brief Title
The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre National de Greffe de Moelle Osseuse

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
autologous PBSC transplant
Intervention Description
optimal timining of a second autologous transplant
Primary Outcome Measure Information:
Title
Overall survival (from randomistion) of the 2 groups at 5 years
Secondary Outcome Measure Information:
Title
Event-free-survival

10. Eligibility

Sex
All
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abderrahman abdelkefi
Organizational Affiliation
Centre National de Greffe de Moelle Osseuse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
abderrahman abdelkefi, MD
Organizational Affiliation
Centre National de Greffe de Moelle Osseuse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre National de Greffe de Moelle Osseuse
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
15968290
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.
Results Reference
result
PubMed Identifier
17875806
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.
Results Reference
derived

Learn more about this trial

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

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