NCT00555100已完成1 期
A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
适应症
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
- 15
- 试验地点
- 5
- 主要终点
- DLT
研究概览
简要总结
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.
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
- •Subjects with previously treated multiple myeloma
- •Measurable levels of m-protein in serum >= 0.5 g/dL [5g/L]) or urine (>= 0.2 g excreted in a 24-hour collection sample)
- •ECOG performance status of 0 - 2
- •Willing to follow pregnancy precautions
排除标准
- •Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years
- •Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
- •Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
- •Patients with posterior subcapsular cataracts
- •Patients with mental illness
- •Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study
- •Pregnant or lactating females
- •Grade 2 or worse neuropathy
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,000cells/mL Platelet count < 75,000/mL Serum creatinine > 2.5 mg/dL Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug
- •Patients with scars from a recent viscus operation
- •Patients with history of a desquamating (blistering) rash while taking thalidomide
- •Patients with prior use of lenalidomide
- •Patients with known HIV positivity.
- •Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy.
- •Patients with known history of hypersensitivity to dexamethasone.
结局指标
主要结局
DLT
时间窗: first cycle (28 days)
次要结局
- Efficacy (M-protein)(24 weeks)
研究者
研究点 (5)
Loading locations...
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