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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286675
• Other study ID #: 10-346
• Status: Completed
• Phase: Early Phase 1
• Start date: March 2011
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Eltrombopag
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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