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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag | Experimental | 0 mg Eltrombopag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Berliner, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level |
| 1 year |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |