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:
Dana-Farber Cancer Institute
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Multiple Myeloma |
Drug: Eltrombopag |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 16 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Eltrombopag |
Drug: Eltrombopag
oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
Other Name: SB-497-115-GR
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286675
Contacts
| Contact: Nancy Berliner, MD | 617-732-5840 | nberliner@partners.org |
Locations
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Nancy Berliner, MD 617-732-5840 nberliner@partners.org | |
| Principal Investigator: Nancy Berliner, MD | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | Nancy Berliner, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Nancy Berliner, MD, Chief, Division of Hematology, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01286675 History of Changes |
| Other Study ID Numbers: | 10-346 |
| Study First Received: | January 28, 2011 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
ASCT G-CSF |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013