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

Phase 2

Completed

• Conditions: Myeloma
• Interventions: Drug: reduced intensity conditioning

• Registration Number: NCT00466674
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-26
• Study First Posted: 2007-04-27
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogenic Transplant	reduced intensity conditioning	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Mohamad Sobh; 🇫🇷 Lyon, France