NCT01568294已完成1 期
A Phase 1, Multicenter, Open-label, Dose-escalation Study in Japan to Determine the Tolerated Dose and to Evaluate the Safety, Efficacy, and Pharmacokinetics of Pomalidomide Alone or in Combination With Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
研究概览
简要总结
The purpose of this study is to determine the tolerated dose of pomalidomide and also to evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with refractory or relapsed and refractory multiple myeloma.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ≥ 20 years of age at the time of signing the informed consent document
- •The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- •Must be able to adhere to the study visit schedule and other protocol requirements
- •Subjects must have documented diagnosis of multiple myeloma and have measurable disease
- •All subjects must have had at least 2 prior lines of anti-myeloma therapy. Induction therapy followed by stem cell transplant and consolidation/maintenance will be considered as one line
- •All subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last anti-myeloma therapy.
- •Primary refractory: Subjects who have never achieved any response better than progressive disease (PD) to any previous line of anti-myeloma therapy.
- •Relapsed and refractory: Subjects who have relapsed after having achieved at least stable disease (SD) to at least one prior regimen and then developed progressive disease (PD) on or within 60 days of completing their last anti-myeloma therapy.
- •Subjects must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen).
- •All subjects must have received adequate prior alkylator therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
排除标准
- •Pregnant or breastfeeding females
- •Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
- •≥ Grade 3 rash during prior thalidomide or lenalidomide therapy
- •Patients unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,000/µL
- •Platelet count < 75,000/µL for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
- •Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
- •Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- •Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
- •Serum glutamic oxaloacetic transaminase (SGOT) /aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT) /alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
- •Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinaemia
- •Peripheral neuropathy ≥ Grade 2
- •Patients who received any of the following within the last 14 days of initiation of study treatment:
- •Plasmapheresis
- •Major surgery (kyphoplasty is not considered major surgery)
- •Radiation therapy
- •Use of any anti-myeloma drug therapy
研究组 & 干预措施
pomalidomide
Experimental
Patients will receive pomalidomide orally on Days 1-21 of each 28-day cycle until when/if a discontinuation criterion, e.g., disease progression, development of an unacceptable toxicity, voluntary withdrawal, or pomalidomide is in market for the target indication.
干预措施: pomalidomide (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
时间窗: Up to 28 Days
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
次要结局
- Time to Response(Up to 28 days)
- Estimate of the terminal elimination half-life in plasma (t1/2)(Up to 28 days)
- Area under the plasma concentration-time curve (AUC0-t)(Up to 28 days)
- Myeloma response(Up to 28 days)
- Maximum observed plasma concentration (Cmax)(Up to 28 days)
- Apparent total plasma clearance (CL/F)(Up to 28 days)
- Apparent total volume of distribution (Vz/F)(Up to 28 days)
- Safety (the number of participants with adverse events, incidence, severity, causality)(Up to 2 years)
- Progression-free survival(Up to 28 days)
- Time to maximum observed plasma concentration (tmax)(Up 28 days)
- Duration of Response(Up to 28 days)
研究者
研究点 (8)
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