An observational study in Multiple Myeloma, Myelodysplastic Syndromes and Lymphoma, sponsored by Qianfoshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Qianfoshan Hospital · Observational
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 38 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with different diagnosis are eligible if they were above the age of 18 and received lenalidomide treatment.
Exclusion Criteria:
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.
Time frame: 2 years
genotype
Genotypes of patients needed to be determined include ABCB1 3435 C\>T, ABCB1 1236 A\>G and ABCB1 2677 A\>C/T.
Time frame: 1 month
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Qianfoshan Hospital