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 January 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: January 3, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2011

Last Updated Date

January 3, 2013

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01286675 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: Eltrombopag

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

Other Name: SB-497-115-GR

Study Arm (s)

Experimental: Eltrombopag

Intervention: Drug: Eltrombopag

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nancy Berliner, MD

617-732-5840

nberliner@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01286675

Other Study ID Numbers ^ICMJE

10-346

Has Data Monitoring Committee

Yes

Responsible Party

Nancy Berliner, MD, Dana-Farber Cancer Institute

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nancy Berliner, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

January 2013

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

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