Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT
- Registration Number
- NCT01286675
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eltrombopag Eltrombopag 0 mg Eltrombopag
- Primary Outcome Measures
Name Time Method Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level. 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. 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 1 year Evaluate the number of apheresis procedures required to obtain at least 2 x 10\^6 CD34+ cells/kg at each dose level
- Secondary Outcome Measures
Name Time Method Evaluate the median fold increase in platelet counts at each of the dose levels 1 year Evaluate the median fold increase in platelet counts at each of the dose levels
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level 1 year Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States