Clinical trial NCT00466674: Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myeloma
Keywords: Myeloma
RICT
conditioning
allograft
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).
timeFrame: 3 years
Secondary outcomes:
measure: Haematological recovery
timeFrame: 3 years
measure: Engraftment rate and graft failure rate
timeFrame: 3 years
measure: The tolerance of Bortezomib after AlloHCST
timeFrame: 5 years
measure: CR (Complete Response) length rate defined by Bladé criteria.
timeFrame: 5 years
measure: Incidence and severity of acute and chronic GVHD
timeFrame: 5 years
measure: Outcome of GVHD under treatment by Bortezomib
timeFrame: 5 years
measure: Chimerism study by competitive PRC
timeFrame: 5 years
measure: Immunological study of the graft (ancillary study)
timeFrame: 5 years
measure: Study of immunological recovery by the recipient
timeFrame: 5 years
measure: TRM = Transplant- Related Mortality at 3 months
timeFrame: 3 months
measure: TRM = Transplant- Related Mortality at 1 year
timeFrame: 1 year
measure: Study of quality of life
timeFrame: 5 years
measure: Global survival at 3 years and 5 years
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Mohamad Sobh
Study officials:
affiliation: Hospices Civils de Lyon
name: Mauricette Michallet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michallet M, Sobh M, El-Cheikh J, Morisset S, Sirvent A, Reman O, Cornillon J, Tabrizi R, Milpied N, Harousseau JL, Labussiere H, Nicolini FE, Attal M, Moreau P, Mohty M, Blaise D, Avet-Loiseau H. Evolving strategies with immunomodulating drugs and tandem autologous/allogeneic hematopoietic stem cell transplantation in first line high risk multiple myeloma patients. Exp Hematol. 2013 Dec;41(12):1008-15. doi: 10.1016/j.exphem.2013.08.003. Epub 2013 Aug 29.