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The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel biological agent used in the treatment of multiple myeloma in preventing graft-versus-host disease, after stem cells transplantation from unrelated donors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carfilzumib | Experimental | Carfilzomib at a dose of 20mg/m2 I.V. will be administrated at day 1, 2 post infusion of the stem cell (SC) graft to the first 10 patients. If no > grade II toxicity* the next 10 patients will receive Carfilzomib (27 mg/m2) at day 1,2 and 8, 9, 15 and 16. If no > grade II toxicity* the next 10 patients will receive 2-3 cycles of Carfilzomib (27 mg/m2) administered at day 1,2 8,9,15 and 16 post SC graft infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carfilzumib | Drug | carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| incidence of acute graft-versus host disease | We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of chronic graft-versus-host disease | We will evaluate the progression of acute graft-versus-host disease to chronic graft-versus-host disease and the grading and organ involvement. | 1 year |
| survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnon Nagler, MD | Contact | 972 3 530 5830 | a.nagler@sheba.health.gov.il | |
| Avichai Shimoni, MD | Contact | 972 3 530 5830 | ashimoni@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Arnon Nagler, MD | Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32873915 | Derived | Shimoni A, Shem-Tov N, Yerushalmi R, Danylesko I, Nagler A. Carfilzomib combined with cyclosporine and methotrexate for the prevention of graft-versus-host disease after allogeneic stem-cell transplantation from unrelated donors. Bone Marrow Transplant. 2021 Feb;56(2):451-456. doi: 10.1038/s41409-020-01044-5. Epub 2020 Sep 2. |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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We will evaluate overall and disease-free survival after stem cell transplantation
| 2 years |