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Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT

Early Phase 1
Completed
Conditions
Multiple Myeloma
Interventions
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
EltrombopagEltrombopag0 mg Eltrombopag
Primary Outcome Measures
NameTimeMethod
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 level1 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
NameTimeMethod
Evaluate the median fold increase in platelet counts at each of the dose levels1 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 level1 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

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