Trial Information
Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning (IFM 2005-03)
Inclusion Criteria:
- Major patients not under guardianship
- Myeloma with high b2 microglobulin level (> 3 mg/l) and/or chromosome 13 deletion,
and/or translocation t(4;14) stage I DS with high evolutive potential or stage II,
III DS.
AND
- With response >= 50% and <= 90% after the first AutoHSCT (IFM 2005 01). The
evaluation must be performed within 2 months after the first AutoHSCT.
- with an HLA identical related or unrelated donor ( match 10/10).
- Donor and recipient must have signed a written informed consent.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Mauricette Michallet, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civils de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2005.385
NCT ID:
NCT00466674
Start Date:
January 2007
Completion Date:
May 2015
Related Keywords:
- Multiple Myeloma
- Myeloma
- RICT
- conditioning
- allograft
- Multiple Myeloma
- Neoplasms, Plasma Cell