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Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06069024
Collaborator
(none)
60
Enrollment
1
Location
31.5
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide
    Actual Study Start Date :
    Oct 15, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    May 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Affiliated Hospital of Shandong First Medical University Jinan Shandong China

    Sponsors and Collaborators

    • Qianfoshan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xin Huang, Chief pharmacist, Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT06069024
    Other Study ID Numbers:
    • QY-SH-2021-LD-PK-001
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Myelodysplastic Syndromes

    Study Results

    No Results Posted as of Oct 5, 2023