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| ID | Type | Description | Link |
|---|---|---|---|
| OBS13612 | Other Identifier | Sanofi |
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| Name | Class |
|---|---|
| European Society for Blood and Marrow Transplantation | NETWORK |
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Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization [31 July 2009] and 31 July 2014).
The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database.
The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration | 5 years |
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Inclusion Criteria: Patients treated with plerixafor who have 1 or more of the following:
Exclusion Criteria:
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Patients treated off-label with plerixafor.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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