Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069024
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2023-09-26
Brief Title:
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pharmacokineticPPK model of lenalidomide and explore factors associated with the adverse events of lenalidomide from a pharmacokineticPK 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None