A Phase II Study of Eltrombopag for the Treatment of Thrombocytopenia in Patients Undergoing Therapy for Relapsed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Migration Arm
Administration of eltrombopag to support platelets during chemotherapy
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
To determine whether eltrombopag administration results in an increased number of participants with adverse events.
Maintenance of Platelet Count
时间窗: 2 years
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
次要结局
- Incidence of Grade 3/4 Thrombocytopenic Events(2 years)
研究者
Nancy Berliner, MD
Principal Investigator
Dana-Farber Cancer Institute