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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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Nancy Berliner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-346

NCT ID:

NCT01286675

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • ASCT
  • G-CSF
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Dana Farber Cancer InstituteBoston, Massachusetts  02115