NCT01286675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P50-P75 for early_phase_1 multiple-myeloma

Timeline
Completed

Started Mar 2011

Longer than P75 for early_phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

5.8 years

First QC Date

January 28, 2011

Last Update Submit

February 27, 2019

Conditions

Multiple Myeloma

Keywords

ASCTG-CSF

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 year

  • 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

    1 year

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

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

    1 year

Secondary Outcomes (2)

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

    1 year

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

    1 year

Study Arms (1)

Eltrombopag

EXPERIMENTAL

0 mg Eltrombopag

Drug: Eltrombopag

Interventions

EltrombopagDRUG

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

Also known as: SB-497-115-GR
Eltrombopag

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Nancy Berliner, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Hematology

Study Record Dates

First Submitted

January 28, 2011

First Posted

January 31, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

US(1)