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

NCT00466674 | Completed Phase 2 DMC

• 1 other identifier: 2005.385
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Myeloma

Keywords

Myeloma; RICT; conditioning; allograft

Outcome Measures

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).

  3 years

Secondary Outcomes (13)

• Haematological recovery

  3 years

• Engraftment rate and graft failure rate

  3 years

• The tolerance of Bortezomib after AlloHCST

  5 years

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

  5 years

• Incidence and severity of acute and chronic GVHD

  5 years

Study Arms (1)

Allogenic Transplant

EXPERIMENTAL

Drug: reduced intensity conditioning

Interventions

reduced intensity conditioning DRUG

reduced intensity conditioning for allogenic transplant

Allogenic Transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Mohamad Sobh

Lyon, 69437, France

Location

Related Publications (1)

• 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.

  PMID: 23994781 RESULT

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Mauricette Michallet, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)