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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01286675
Other study ID # 10-346
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date March 2011
Est. completion date December 2018

Study information

Verified date February 2019
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 2018
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eltrombopag
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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 1 year
Secondary 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 1 year
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