Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466674
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2007-04-26
Brief 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
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IFM 2005-03
Brief Summary:
Donor mobilization
Donor will be mobilized with G-CSF Granocyte sub-cutaneous 10 µgkgday 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 4x106kg 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 mgm²
D-4 Fludarabine 30 mgm² Busilvex 08 mgkg every 6 h
D-3 Fludarabine 30 mgm² Busilvex 08 mgkg every 6 h
D-2 Fludarabine 30 mgm² ATG Genzyme 25 mgKg
D-1 Fludarabine 30 mgm² ATG Genzyme 25 mgKg GVHD Prophylaxis CsA alone at 3 mg kg Methotrexate D1 D3 and D6 only in case of minor ABO incompatibility and with an anti AB antibodies titer 132
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
Donor will be mobilized with G-CSF Granocyte sub-cutaneous 10 µgkgday 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 4x106kg 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 mgm²
D-4 Fludarabine 30 mgm² Busilvex 08 mgkg every 6 h
D-3 Fludarabine 30 mgm² Busilvex 08 mgkg every 6 h
D-2 Fludarabine 30 mgm² ATG Genzyme 25 mgKg
D-1 Fludarabine 30 mgm² ATG Genzyme 25 mgKg GVHD Prophylaxis CsA alone at 3 mg kg Methotrexate D1 D3 and D6 only in case of minor ABO incompatibility and with an anti AB antibodies titer 132
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None