Myeloma
Conditions
Keywords
Myeloma, RICT, conditioning, allograft
Brief 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
Interventions
reduced intensity conditioning for allogenic transplant
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions). | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Engraftment rate and graft failure rate | 3 years |
| The tolerance of Bortezomib after AlloHCST | 5 years |
| CR (Complete Response) length rate defined by Bladé criteria. | 5 years |
| Incidence and severity of acute and chronic GVHD | 5 years |
| Outcome of GVHD under treatment by Bortezomib | 5 years |
| Chimerism study by competitive PRC | 5 years |
| Haematological recovery | 3 years |
| Study of immunological recovery by the recipient | 5 years |
| TRM = Transplant- Related Mortality at 3 months | 3 months |
| TRM = Transplant- Related Mortality at 1 year | 1 year |
| Study of quality of life | 5 years |
| Global survival at 3 years and 5 years | 3 and 5 years |
| Immunological study of the graft (ancillary study) | 5 years |
Countries
France
Outcome results
None listed