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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Eltrombopag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eltrombopag<br>0 mg Eltrombopag | Drug: Eltrombopag<br>* oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15<br>* Other names: SB-497-115-GR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level. | Evaluate the median fold increase in the number of CD34+ cells/kg mobilized 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 | Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level | 1 year | 
| Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor. | Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the median fold increase in platelet counts at each of the dose levels | 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 | Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASCT, G-CSF