MyelomaPhase 2IFM 2005-03NCT00466674
Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning
A Phase 2 study testing reduced intensity conditioning in people with Myeloma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myeloma
- What is being tested?
- reduced intensity conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Donor mobilization :
Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.
Read more
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
- Being tested
- reduced intensity conditioning
- Keywords
- Myeloma, RICT, conditioning, allograft
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced intensity conditioningDrug
reduced intensity conditioning for allogenic transplant
| Study group | Role | What they receive |
|---|---|---|
| Allogenic Transplant | Experimental | Not described Receives: Drug: reduced intensity conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).
Measured: 3 years
Secondary outcomes (13)
Haematological recovery
Measured: 3 years
Engraftment rate and graft failure rate
Measured: 3 years
The tolerance of Bortezomib after AlloHCST
Measured: 5 years
CR (Complete Response) length rate defined by Bladé criteria.
Measured: 5 years
Incidence and severity of acute and chronic GVHD
Measured: 5 years
Outcome of GVHD under treatment by Bortezomib
Measured: 5 years
Chimerism study by competitive PRC
Measured: 5 years
Immunological study of the graft (ancillary study)
Measured: 5 years
Study of immunological recovery by the recipient
Measured: 5 years
TRM = Transplant- Related Mortality at 3 months
Measured: 3 months
TRM = Transplant- Related Mortality at 1 year
Measured: 1 year
Study of quality of life
Measured: 5 years
Global survival at 3 years and 5 years
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricette Michallet, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466674
- Sponsor's protocol ID
- 2005.385
- Acronym
- IFM 2005-03
- Status last verified
- Dec 2025
- First submitted
- 26 Apr 2007
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23994781
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00466674
- Acronym / sponsor ID
- IFM 2005-03 / 2005.385
- Conditions
- Myeloma
- Keywords
- Myeloma, RICT, conditioning, allograft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogenic Transplant | Experimental | Drug: reduced intensity conditioning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduced intensity conditioningreduced intensity conditioning for allogenic transplant | Drug | Allogenic Transplant |
Primary outcome
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
13 secondary outcomes
Haematological recovery
Time frame: 3 years
Engraftment rate and graft failure rate
Time frame: 3 years
The tolerance of Bortezomib after AlloHCST
Time frame: 5 years
CR (Complete Response) length rate defined by Bladé criteria.
Time frame: 5 years
Incidence and severity of acute and chronic GVHD
Time frame: 5 years
Outcome of GVHD under treatment by Bortezomib
Time frame: 5 years
Chimerism study by competitive PRC
Time frame: 5 years
Immunological study of the graft (ancillary study)
Time frame: 5 years
Study of immunological recovery by the recipient
Time frame: 5 years
TRM = Transplant- Related Mortality at 3 months
Time frame: 3 months
TRM = Transplant- Related Mortality at 1 year
Time frame: 1 year
Study of quality of life
Time frame: 5 years
Global survival at 3 years and 5 years
Time frame: 3 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 23994781Michallet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricette Michallet, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing reduced intensity conditioning in people with Myeloma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.