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)

Civil Hospices of Lyon

Status and phase: Completed; Phase 2

Conditions: Myeloma

Treatments: Drug: reduced intensity conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00466674

2005.385

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

Allogenic Transplant

Experimental group

Treatment:

Drug: reduced intensity conditioning