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)

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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