A Pilot Study to Evaluate the Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization and Ex Vivo Colony Proliferative Capacity in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
研究概览
简要总结
Eltrombopag may improve the cell collection available for Autologous Stem Cell Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT will increase the number of blood cells collected and reduce the number of times blood needs to be collected. This study will also determine the highest dose of Eltrombopag that can be used without causing serious side effects.
详细描述
Subjects will receive standard treatment for autologous stem cell transplant. Subjects will be assigned to receive no Eltrombopag or one of three dose levels of Eltrombopag. Subjects will receive oral Eltrombopag on days 2-15 of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma
- •Stable or responsive disease after at least 2 cycles of conventional chemotherapy
- •Slated to undergo autologous peripheral blood stem cell transplant
- •Normal organ and marrow function
排除标准
- •Myocardial infarction within 6 months of treatment
- •Receiving other study agents
- •Pregnant or breastfeeding
- •Uncontrolled intercurrent illness
- •Evidence of active or recent history of thromboembolic disease
- •Previous history of primary platelet disorder or bleeding disorder
- •History of a different malignancy unless disease free for at least 5 years
研究组 & 干预措施
Eltrombopag
0 mg Eltrombopag
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
时间窗: 1 year
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
时间窗: 1 year
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level
时间窗: 1 year
Evaluate the number of apheresis procedures required to obtain at least 2 x 10\^6 CD34+ cells/kg at each dose level
次要结局
- Evaluate the median fold increase in platelet counts at each of the dose levels(1 year)
- Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level(1 year)
研究者
Nancy Berliner, MD
Chief, Division of Hematology
Dana-Farber Cancer Institute