Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- drug blood concentration
研究概览
简要总结
This is a non-intervention, prospective, open-label and observational clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic(PPK) model of lenalidomide and explore factors associated with the adverse events of lenalidomide from a pharmacokinetic(PK) perspective.
详细描述
Studies have found that there is significant interpatient variability in the plasma concentration of lenalidomide, and the PK parameters of lenalidomide do not affect its efficacy but may be correlated with its toxicity. Therefore, the investigators plan to conduct a PPK study on lenalidomide to identify factors contributing to interpatient PK differences, thus refining regimens to mitigate its adverse reactions, in the hope of optimizing the clinical application of lenalidomide. At least 50 patients are planned to be included. It should be noted that the study does not interfere with the patients' treatment plans. Except for the discomfort during blood sampling, patients will not be exposed to any risks.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients who are above the age of 18
- •Patients who receive lenalidomide treatment
排除标准
- •Patients have received other investigational systemic drugs
- •The clinical data are deemed insufficient
- •There appear other factors that rendered them ineligible.
结局指标
主要结局
drug blood concentration
时间窗: 2 years
Blood samples of patients who took lenalidomide were collected by opportunistic blood collection, which were used for concentration determination by using HPLC/MS. Lenalidomide blood levels in patients were prevalent between 1-1000 ng/ml.
genotype
时间窗: 1 month
Genotypes of patients needed to be determined include ABCB1 3435 C\>T, ABCB1 1236 A\>G and ABCB1 2677 A\>C/T.
次要结局
未报告次要终点
研究者
Xin Huang
Chief pharmacist
Qianfoshan Hospital