Overview

Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
Donor mobilization : Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days. Hematopoïetic Stem Cell Harvest: By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >= 2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG - D-5 : Fludarabine (30 mg/m²) - D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h) - D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h) - D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) - D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer> 1/32. Transplant : HSC at D0 • 3 months after Transplantation : Disease Evaluation : - If CR : Supervision. Then if progression: 4 cycles of Bortezomib. - If no CR : Bortezomib (4 cycles) • Evaluation after Bortezomib cycles - If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospices Civils de Lyon
Criteria
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.