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Completed

NCT Number: NCT01286675

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eltrombopag

Drug

oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15

Other names: SB-497-115-GR

Primary outcomes

  1. Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.

    Time frame: 1 year

    Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.

  2. 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

    Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level

  3. Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.

    Time frame: 1 year

    Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.

Secondary outcomes

  1. Evaluate the median fold increase in platelet counts at each of the dose levels

    Time frame: 1 year

    Evaluate the median fold increase in platelet counts at each of the dose levels

  2. Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level

    Time frame: 1 year

    Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Jan 31, 2011
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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