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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.
Verified August 2016 by Nancy Berliner, MD, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286675
First Posted: January 31, 2011
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nancy Berliner, MD, Dana-Farber Cancer Institute
  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: Intervention Model: Single Group Assignment
Masking: None (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 Nancy Berliner, MD, 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 ]
  • 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 ]
  • Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Evaluate the median fold increase in platelet counts at each of the dose levels [ Time Frame: 1 year ]
  • Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level [ Time Frame: 1 year ]

Estimated Enrollment: 16
Study Start Date: March 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 28, 2011
First Posted: January 31, 2011
Last Update Posted: August 2, 2016
Last Verified: August 2016

Keywords provided by Nancy Berliner, MD, 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