NCT00466674

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myeloma

Interventions

Type	Name	Description
DRUG	reduced intensity conditioning	reduced intensity conditioning for allogenic transplant

Timeline

• Start date: 2007-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2007-04-27
• Last updated: 2025-12-19

Locations

1 site across 1 country: France