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

NCT ID: NCT01286675

Last Updated: 2019-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Eltrombopag

0 mg Eltrombopag

Group Type EXPERIMENTAL

Eltrombopag

Intervention Type DRUG

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

Interventions

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Eltrombopag

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

Intervention Type DRUG

Other Intervention Names

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SB-497-115-GR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Nancy Berliner, MD

Chief, Division of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Berliner, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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10-346

Identifier Type: -

Identifier Source: org_study_id

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