IFM 2005-03: Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT00466674

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myeloma	Drug: reduced intensity conditioning	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Allogenic Transplant	Drug: reduced intensity conditioning reduced intensity conditioning for allogenic transplant

Arm

Intervention/Treatment

Experimental: Allogenic Transplant

Drug: reduced intensity conditioning

reduced intensity conditioning for allogenic transplant

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Haematological recovery [3 years]
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]
Immunological study of the graft (ancillary study) [5 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.