This pilot clinical trial studies the best dose of eltrombopag olamine when given together with filgrastim in mobilizing stem cells in patients with multiple myeloma undergoing peripheral blood stem cell transplant. Eltrombopag olamine may increase production of platelets. Giving colony-stimulating factors, such as filgrastim helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Giving eltrombopag olamine together with filgrastim may improve the stem cell collection available for peripheral blood stem cell transplant in patients with multiple myeloma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01286675.
PRIMARY OBJECTIVES:
I. Evaluate the median fold increase in the number of cluster of differentiation (CD)34+cells/kg mobilized at each of the dose levels.
II. Evaluate the number of apheresis procedures required to obtain at least 2x10^6 CD34+ cells/kg at each of the dose levels.
III. Determine the maximum tolerated dose of eltrombopag (eltrombopag olamine) with G-CSF (filgrastim).
SECONDARY OBJECTIVES:
I. Evaluate the median fold increase in platelet counts at each of the dose levels.
II. Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each of the dose levels.
OUTLINE: This is a dose-escalation study of eltrombopag olamine.
ARM I: Patients receive filgrastim subcutaneously (SC) and eltrombopag olamine orally (PO) daily beginning on day 2, 3, or 4 through completion of pheresis for up to 14 doses. Beginning 3-4 weeks later, patients receive filgrastim SC on days 1-8.
ARM II: Patients receive filgrastim SC daily beginning on day 2, 3, or 4 through completion of pheresis for up to 14 doses.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorNancy Berliner