Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma
Eltrombopag is a compound that may help stimulate the production of platelets. This drug has been used in treatment of low platelet counts caused by a disorder called idiopathic thrombocytopenic purpura and information from those other research studies suggests that Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma in this research study.
In this research study,the investigators are trying to determine if Eltrombopag is effective in maintaining platelet counts in patients who are being treated for relapsed multiple myeloma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Eltrombopag for the Treatment of Thrombocytopenia in Patients Undergoing Therapy for Relapsed Multiple Myeloma|
- Maintenance of Platelet Count [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy
- Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To determine whether eltrombopag administration results in an increased number of participants with adverse events.
- Incidence of Grade 3/4 Thrombocytopenic Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy
|Study Start Date:||April 2012|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Migration Arm
Administration of eltrombopag to support platelets during chemotherapy
100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy
You will take eltrombopag during two consecutive cycles of chemotherapy. During these two cycles you will be asked to complete the following for the research study in addition to any clinical exams or procedures that your regular doctor may order:
Study Drug(s): If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 27 days during which time you will be taking the study drug for 11 days on days 1 through 11.
Clinical Exams: You will have a physical exam on days 1, 11, and 21 of both cycles. You will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. Your vital signs will be collected during this exam.
Performance status: Your ability to perform daily tasks will be assessed on days 1 and 27 of both cycles.
Blood Tests: You will have tests to check for safety performed on days 1, 7, 11, 20, and 27 of both cycles. You will have approximately 1-2 teaspoons of blood collected.
Concurrent Medications: Any changes to your medications will be recorded. Adverse Events: You be continually monitored for any changes to you health or well-being while you are on this study.
You will complete all subsequent cycles of chemotherapy procedures per standard of care for DFCI. During the subsequent cycles, you will not take eltrombopag.
After the final dose of the study drug: On Day 1 of cycle 3 of chemotherapy, you will complete the end of study/off study evaluations. The following procedures will be completed:
- Physical Exam, including vitals signs
- Performance status, which evaluates how you are able to carry on with your usual activities.
- Tumor Measurements: We will assess your tumor by blood tests and/or bone marrow aspirate and biopsy. If clinically indicated, you may have CT scans, bone scans or skeletal surveys
- Blood tests, routine tests to check for safety
- Concurrent Medications: Any changes to your medications will be recorded.
We would also like to keep track of your medical condition for thirty days after your last dose of study drug. We would like to do this by having you return to have your blood counts checked once a week for 4 weeks and by calling you to check your condition and any changes to your health or well-being that may have occurred since you last took the study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484314
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Nancy Berliner, MD||Dana-Farber Cancer Institute|