Effect of Eltrombopag Plus Granulocyte Colony-stimulating Factor (G-CSF) on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplant (ASCT)
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
ASCT, G-CSF
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Eltrombopag
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Nancy Berliner, MD - 617-732-5840 - nberliner@partners.org
Start Date
March 2011
Sponsors
Dana-Farber Cancer Institute
Source
Dana-Farber Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page