Status:
TERMINATED
Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Thrombocytopenia
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 purpu...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Participants must have histologically confirmed multiple myeloma that is relapsed or refractory
- Patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
- Performance status (ECOG) ≤ 2
- Not pregnant or breastfeeding
Exclusion
- Participants with a history of rapidly progressive disease \[increase in tumor size (≥ 50%) as defined by standard myeloma markers \], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days
- Participants may not be receiving any other study agents within 21 days prior to entry on the study.
- The use of growth factors other than erythropoiesis stimulating agents or G-CSF (Neupogen or Neulasta) during the study period.
- Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
- Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, AT-III deficiency, etc.), platelet disorder or bleeding disorder.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Individuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01484314
Start Date
April 1 2012
End Date
September 1 2015
Last Update
March 15 2017
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215