Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma

Status: Recruiting
Phase: Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01484314 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-373

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Dana Farber Cancer Institute at Milford

Overall PI:
Gary Vanasse. M.D., Brigham and Women's Hospital

Site-responsible Investigators:
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial
Andrew Yee, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Muriel Gannon, 617-632-4597, mgannon@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - 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 Criteria: - 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.
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