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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Eltrombopag
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring ASCT, G-CSF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eltrombopag

Arm Description

0 mg Eltrombopag

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
January 28, 2011
Last Updated
February 27, 2019
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01286675
Brief Title
Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
ASCT, G-CSF

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eltrombopag
Arm Type
Experimental
Arm Description
0 mg Eltrombopag
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Other Intervention Name(s)
SB-497-115-GR
Intervention Description
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
Primary Outcome Measure Information:
Title
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Description
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Time Frame
1 year
Title
Evaluate the number of apheresis procedures required to obtain at least 2 x 10^6 CD34+ cells/kg at each dose level
Description
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
Title
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
Description
Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluate the median fold increase in platelet counts at each of the dose levels
Description
Evaluate the median fold increase in platelet counts at each of the dose levels
Time Frame
1 year
Title
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
Description
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Berliner, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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