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
  Purpose

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.


Condition Intervention
Multiple Myeloma
Drug: Eltrombopag

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: March 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eltrombopag Drug: Eltrombopag
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
Other Name: SB-497-115-GR

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286675

Contacts
Contact: Nancy Berliner, MD 617-732-5840 nberliner@partners.org

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Berliner, MD    617-732-5840    nberliner@partners.org   
Principal Investigator: Nancy Berliner, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Nancy Berliner, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Nancy Berliner, MD, Chief, Division of Hematology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01286675     History of Changes
Other Study ID Numbers: 10-346
Study First Received: January 28, 2011
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
ASCT
G-CSF

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014