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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)


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Multiple Myeloma

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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

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