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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)

Primary Purpose

Myeloma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

reduced intensity conditioning

About this trial

This is an interventional treatment trial for Myeloma focused on measuring Myeloma, RICT, conditioning, allograft

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mohamad Sobh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogenic Transplant

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Haematological recovery

Engraftment rate and graft failure rate

The tolerance of Bortezomib after AlloHCST

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

Incidence and severity of acute and chronic GVHD

Outcome of GVHD under treatment by Bortezomib

Chimerism study by competitive PRC

Immunological study of the graft (ancillary study)

Study of immunological recovery by the recipient

TRM = Transplant- Related Mortality at 3 months

TRM = Transplant- Related Mortality at 1 year

Study of quality of life

Global survival at 3 years and 5 years

Full Information

NCT ID

NCT00466674

First Posted

April 26, 2007

Last Updated

January 14, 2014

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT00466674

Brief 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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloma

Keywords

Myeloma, RICT, conditioning, allograft

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allogenic Transplant

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

reduced intensity conditioning

Intervention Description

reduced intensity conditioning for allogenic transplant

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Haematological recovery

Time Frame

3 years

Title

Engraftment rate and graft failure rate

Time Frame

3 years

Title

The tolerance of Bortezomib after AlloHCST

Time Frame

5 years

Title

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

Time Frame

5 years

Title

Incidence and severity of acute and chronic GVHD

Time Frame

5 years

Title

Outcome of GVHD under treatment by Bortezomib

Time Frame

5 years

Title

Chimerism study by competitive PRC

Time Frame

5 years

Title

Immunological study of the graft (ancillary study)

Time Frame

5 years

Title

Study of immunological recovery by the recipient

Time Frame

5 years

Title

TRM = Transplant- Related Mortality at 3 months

Time Frame

3 months

Title

TRM = Transplant- Related Mortality at 1 year

Time Frame

1 year

Title

Study of quality of life

Time Frame

5 years

Title

Global survival at 3 years and 5 years

Time Frame

3 and 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauricette Michallet, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mohamad Sobh

City

Lyon

ZIP/Postal Code

69437

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23994781

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.

Results Reference

derived

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

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