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

Myeloma Clinical Trial

— IFM 2005-03  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466674
• Other study ID #: 2005.385
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2007
• Last updated: January 14, 2014
• Start date: January 2007
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• reduced intensity conditioning
reduced intensity conditioning for allogenic transplant

Locations

Country	Name	City	State
France	Mohamad Sobh	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).		3 years	Yes
Secondary	Haematological recovery		3 years	Yes
Secondary	Engraftment rate and graft failure rate		3 years	Yes
Secondary	The tolerance of Bortezomib after AlloHCST		5 years	Yes
Secondary	CR (Complete Response) length rate defined by Bladé criteria.		5 years	Yes
Secondary	Incidence and severity of acute and chronic GVHD		5 years	Yes
Secondary	Outcome of GVHD under treatment by Bortezomib		5 years	Yes
Secondary	Chimerism study by competitive PRC		5 years	No
Secondary	Immunological study of the graft (ancillary study)		5 years	No
Secondary	Study of immunological recovery by the recipient		5 years	No
Secondary	TRM = Transplant- Related Mortality at 3 months		3 months	Yes
Secondary	TRM = Transplant- Related Mortality at 1 year		1 year	Yes
Secondary	Study of quality of life		5 years	No
Secondary	Global survival at 3 years and 5 years		3 and 5 years	Yes