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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogenic Transplant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduced intensity conditioning | Drug | reduced intensity conditioning for allogenic transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Haematological recovery | 3 years | |
| Engraftment rate and graft failure rate | 3 years | |
| The tolerance of Bortezomib after AlloHCST |
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Inclusion Criteria:
AND
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| Name | Affiliation | Role |
|---|---|---|
| Mauricette Michallet, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamad Sobh | Lyon | 69437 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23994781 | Result | 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. |
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| 5 years |
| CR (Complete Response) length rate defined by Bladé criteria. | 5 years |
| Incidence and severity of acute and chronic GVHD | 5 years |
| Outcome of GVHD under treatment by Bortezomib | 5 years |
| Chimerism study by competitive PRC | 5 years |
| Immunological study of the graft (ancillary study) | 5 years |
| Study of immunological recovery by the recipient | 5 years |
| TRM = Transplant- Related Mortality at 3 months | 3 months |
| TRM = Transplant- Related Mortality at 1 year | 1 year |
| Study of quality of life | 5 years |
| Global survival at 3 years and 5 years | 3 and 5 years |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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