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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  

Myeloma Clinical Trial

Official title:
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)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00466674
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase Phase 2
Start date January 2007
Completion date September 2013
View Details
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