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

Early Phase 1CompletedNCT01286675

Dana-Farber Cancer Institute19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

EltrombopagDRUG

oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.

Time frame: 1 year

Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level

Evaluate the number of apheresis procedures required to obtain at least 2 x 10\^6 CD34+ cells/kg at each dose level

Time frame: 1 year

Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.

Time frame: 1 year

Secondary Outcomes

Evaluate the median fold increase in platelet counts at each of the dose levels

Time frame: 1 year

Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.