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NCT06069024 Clinical Trial

Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

Multiple Myeloma Clinical Trial

Official title:
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06069024
Other study ID # QY-SH-2021-LD-PK-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date May 31, 2023

Study information
Verified date April 2024
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China the First Affiliated Hospital of Shandong First Medical University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary drug blood concentration 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. 2 years
Primary genotype Genotypes of patients needed to be determined include ABCB1 3435 C>T, ABCB1 1236 A>G and ABCB1 2677 A>C/T. 1 month
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