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

Dana-Farber Cancer Institute

Status and phase: Completed; Early Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Eltrombopag

Study type: Interventional

Funder types: Other

Identifiers

NCT01286675

10-346 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Eltrombopag

Experimental group

Description:

0 mg Eltrombopag

Treatment:

Drug: Eltrombopag