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临床试验/NCT02997813
NCT02997813已完成不适用

Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor

Intergroupe Francophone du Myelome9 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
9
主要终点
Total cost of stem cell mobilization procedure (including remobilisation if applicable)

研究概览

简要总结

This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.

All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous hematopoietic stem cell transplantation (ASCT) upfront.
  • Age > 18 years
  • Undergone prior successful peripheral blood stem cell mobilization with Cyclophosphamid or Plerixafor

排除标准

  • Age < 18 years;
  • Primary diagnosis other than Multiple Myeloma

结局指标

主要结局

Total cost of stem cell mobilization procedure (including remobilisation if applicable)

时间窗: 2009-2013

次要结局

  • Number of visits for administration of mobilizing agents(2009-2013)
  • Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)(2009-2013)
  • Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)(2009-2013)
  • Duration (days) of administration of mobilizing agents(2009-2013)
  • Agents used as mobilizing agents(2009-2013)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (9)

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