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Completed

NCT Number: 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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mohamad Sobh

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reduced intensity conditioning

Drug

reduced intensity conditioning for allogenic transplant

Primary outcomes

  1. Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).

    Time frame: 3 years

Secondary outcomes

  1. Haematological recovery

    Time frame: 3 years

  2. Engraftment rate and graft failure rate

    Time frame: 3 years

  3. The tolerance of Bortezomib after AlloHCST

    Time frame: 5 years

  4. CR (Complete Response) length rate defined by Bladé criteria.

    Time frame: 5 years

  5. Incidence and severity of acute and chronic GVHD

    Time frame: 5 years

  6. Outcome of GVHD under treatment by Bortezomib

    Time frame: 5 years

  7. Chimerism study by competitive PRC

    Time frame: 5 years

  8. Immunological study of the graft (ancillary study)

    Time frame: 5 years

  9. Study of immunological recovery by the recipient

    Time frame: 5 years

  10. TRM = Transplant- Related Mortality at 3 months

    Time frame: 3 months

  11. TRM = Transplant- Related Mortality at 1 year

    Time frame: 1 year

  12. Study of quality of life

    Time frame: 5 years

  13. Global survival at 3 years and 5 years

    Time frame: 3 and 5 years

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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)

Acronym: IFM 2005-03

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Apr 27, 2007
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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