Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
研究概览
简要总结
This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.
详细描述
Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
- •Karnofsky Performance Status ≥
- •Less than 30% involvement of marrow with disease.
排除标准
- •> 30% marrow involvement with disease
- •Pregnant women.
研究组 & 干预措施
Plerixafor
All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.
干预措施: Plerixafor (Drug)
Plerixafor
All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.
干预措施: Filgrastim (Drug)
Observation
All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen.
干预措施: Filgrastim (Drug)
结局指标
主要结局
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
时间窗: Day 2 of apheresis
The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.
次要结局
- Economic impact(Day 2 of mobilization and Day +100 after transplantation)
- Kinetics of CD34+ mobilization with early introduction of plerixafor(On Day 1 and Day 2 of apheresis)
- Graft composition(On Day 1 and Day 2 of apheresis)