A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 39
- 主要终点
- Occurrence of a Clinically Significant Thrombocytopenic Event
研究概览
简要总结
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.
All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification
- •Low or Intermediate-1 risk category MDS using the IPSS
- •Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles
- •Eastern Cooperative Oncology (ECOG) performance status of 0-2
- •Subjects must be at least 18 years of age or older
排除标准
- •Prior exposure to >3 cycles of lenalidomide
- •Exposure to lenalidomide within the last 30 days
- •Prior history of leukemia or aplastic anemia
- •Prior history of stem cell transplantation
- •Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before randomization
- •Active or uncontrolled infections
- •Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
- •History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
- •History of venous thrombosis in the past year
- •Received IL-11 within 4 weeks of screening
- •Less than 4 weeks since receipt of any investigational drug or device
- •Have previously received any other thrombopoietic growth factor
- •Pregnant or breast feeding
- •Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
- •Known hypersensitivity to any recombinant E coli-derived product
研究组 & 干预措施
Placebo Part A
Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)
干预措施: Placebo (Drug)
Placebo Part B
Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)
干预措施: Placebo (Drug)
750 mcg AMG 531
750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)
干预措施: AMG 531 (Biological)
750 mcg AMG531 Part B
750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)
干预措施: AMG 531 (Biological)
500 mcg AMG 531
500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)
干预措施: AMG 531 (Biological)
结局指标
主要结局
Occurrence of a Clinically Significant Thrombocytopenic Event
时间窗: Treatment period through interim follow-up visit (up to 16 weeks)
Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.
次要结局
- Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia(Treatment period (up to 16 weeks))
- Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines(Treatment period and post-treatment follow-up (up to 21 weeks))
- Platelet Transfusion(Treatment period (up to 16 weeks))