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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Nancy Berliner, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01286675
First received: January 28, 2011
Last updated: September 3, 2013
Last verified: September 2013

January 28, 2011
September 3, 2013
March 2011
December 2014   (final data collection date for primary outcome measure)
  • Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01286675 on ClinicalTrials.gov Archive Site
  • Evaluate the median fold increase in platelet counts at each of the dose levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Multiple Myeloma
Drug: Eltrombopag
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
Other Name: SB-497-115-GR
Experimental: Eltrombopag
Intervention: Drug: Eltrombopag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Nancy Berliner, MD 617-732-5840 nberliner@partners.org
United States
 
NCT01286675
10-346
Yes
Nancy Berliner, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Nancy Berliner, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP