Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

Completed

• Conditions: Lymphoma; Myelodysplastic Syndromes; Multiple Myeloma

• Registration Number: NCT06069024
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-10-15
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients who are above the age of 18
• Patients who receive lenalidomide treatment

Exclusion Criteria

• Patients have received other investigational systemic drugs
• The clinical data are deemed insufficient
• There appear other factors that rendered them ineligible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
drug blood concentration	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	1 month	Genotypes of patients needed to be determined include ABCB1 3435 C\>T, ABCB1 1236 A\>G and ABCB1 2677 A\>C/T.

Trial Locations

Locations (1)

the First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China