- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286675
Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT
February 27, 2019 updated by: Nancy Berliner, MD, Dana-Farber Cancer Institute
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eltrombopag
0 mg Eltrombopag
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oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the median fold increase in the number of CD34+ cells/kg mobilized at each dose level.
Time Frame: 1 year
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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
Time Frame: 1 year
|
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.
Time Frame: 1 year
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Determine the maximum tolerated dose of eltrombopag with granulocyte colony-stimulating factor.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the median fold increase in platelet counts at each of the dose levels
Time Frame: 1 year
|
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
Time Frame: 1 year
|
Evaluate the median fold increase in hematopoietic colony forming capacity of CD34+ cells at each dose level
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Berliner, MD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
January 28, 2011
First Submitted That Met QC Criteria
January 28, 2011
First Posted (Estimate)
January 31, 2011
Study Record Updates
Last Update Posted (Actual)
March 1, 2019
Last Update Submitted That Met QC Criteria
February 27, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 10-346 (OTHER: Hamilton Health Sciences Research Ethics Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Eltrombopag
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Novartis PharmaceuticalsCompletedPurpura, Thrombocytopenic, IdiopathicRussian Federation
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Fondazione Progetto EmatologiaCompletedChronic Lymphocytic Leukemia | Purpura, Thrombocytopenic, Idiopathic | Non Hodgkin's Lymphoma | Autoimmune Thrombocytopenia | Autoimmune Thrombocytopenic PurpuraItaly
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Weill Medical College of Cornell UniversityNovartisTerminatedImmune ThrombocytopeniaUnited States
-
Institute of Hematology & Blood Diseases Hospital...Xijing Hospital; Xi'an Central Hospital; The Second Hospital of Hebei Medical... and other collaboratorsActive, not recruitingPreviously Treated Primary Immune ThrombocytopeniaChina
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Tel-Aviv Sourasky Medical CenterNovartisRecruitingB Cell Lymphoma | CART TreatmentIsrael
-
Gruppo Italiano Malattie EMatologiche dell'AdultoCompletedPrimacy Immune ThrombocytopeniaItaly
-
Novartis PharmaceuticalsCompletedPurpura, Thrombocytopaenic, Idiopathic
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Nanfang Hospital of Southern Medical UniversityGuangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen... and other collaboratorsUnknownAcute Myeloid Leukemia | Thrombocytopenia | EltrombopagChina
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IRCCS Policlinico S. MatteoCompleted