Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- pharmacokinetic data of lenograstim
研究概览
简要总结
Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: above 17 years, below 65 years old
- •informed consent
- •autologous stem cell transplant candidate among patients with multiple myeloma
排除标准
- •prior history of hematopoetic stem cell transplantation
- •history of failure to mobilize hematopoietic stem cells
- •history of G-CSF administration within 2 weeks before enrollment to this study
研究组 & 干预措施
AM group
Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
干预措施: lenograstim 10 microgram/kg/day (Drug)
PM group
Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5
干预措施: lenograstim 10 microgram/kg/day (Drug)
结局指标
主要结局
pharmacokinetic data of lenograstim
时间窗: on day 1 of apheresis
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
次要结局
- pharmacodynamic data: absolute neutrophil count(on day 1 of apheresis)
- pharmacodynamic data: hematopoietic progenitor cells (HPC)(on day 1 of apheresis)
- pharmacodynamic data: CD34+ cell count by flow cytometry(on day 1 of apheresis)
研究者
Cheolwon Suh
Professor
Asan Medical Center