Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 主要终点
- Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with plerixafor who have 1 or more of the following:
- •Background disease other than lymphoma or multiple myeloma (MM)
- •Are younger than 18 years of age.
- •Received transplant using ex vivo plerixafor-mobilised cells (umbilical cord cell, peripheral blood (PB), bone marrow (BM) cell collection)
- •Received treatment with plerixafor alone (i.e., without granulocyte colony stimulating factor (G-CSF))
- •Contraindication for G-CSF
- •Transplants using plerixafor-mobilised cells from allogeneic donor
- •Received transplant using plerixafor-mobilised bone marrow cells
- •Routes of plerixafor administration other than subcutaneous
- •Patients whose cells do not mobilize poorly
排除标准
- •Adults diagnosed with lymphoma or multiple myeloma (MM) and have been treated with plerixafor according to the European Union (EU) label.
结局指标
主要结局
Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration
时间窗: 5 years
次要结局
未报告次要终点