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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01286675

Enrollment

Registered

2011-01-31

Start date

2011-03-31

Completion date

2018-12-31

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

ASCT, G-CSF

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.

Interventions

DRUGEltrombopag

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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
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.

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026