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)

January 14, 2014 updated by: Hospices Civils de Lyon

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Mohamad Sobh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allogenic Transplant
Drug: reduced intensity conditioning
reduced intensity conditioning for allogenic transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Haematological recovery
Time Frame: 3 years
3 years
Engraftment rate and graft failure rate
Time Frame: 3 years
3 years
The tolerance of Bortezomib after AlloHCST
Time Frame: 5 years
5 years
CR (Complete Response) length rate defined by Bladé criteria.
Time Frame: 5 years
5 years
Incidence and severity of acute and chronic GVHD
Time Frame: 5 years
5 years
Outcome of GVHD under treatment by Bortezomib
Time Frame: 5 years
5 years
Chimerism study by competitive PRC
Time Frame: 5 years
5 years
Immunological study of the graft (ancillary study)
Time Frame: 5 years
5 years
Study of immunological recovery by the recipient
Time Frame: 5 years
5 years
TRM = Transplant- Related Mortality at 3 months
Time Frame: 3 months
3 months
TRM = Transplant- Related Mortality at 1 year
Time Frame: 1 year
1 year
Study of quality of life
Time Frame: 5 years
5 years
Global survival at 3 years and 5 years
Time Frame: 3 and 5 years
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Mauricette MICHALLET, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005.385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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