Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning
NCT ID: NCT00466674
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2007-01-31
2013-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Allogenic Transplant
reduced intensity conditioning
reduced intensity conditioning for allogenic transplant
Interventions
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reduced intensity conditioning
reduced intensity conditioning for allogenic transplant
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Mauricette Michallet, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Mohamad Sobh
Lyon, , France
Countries
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References
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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.
Other Identifiers
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2005.385
Identifier Type: -
Identifier Source: org_study_id