A prospective study of adherence to lenalidomide for multiple myeloma using Medication Event Monitoring System (MEMS) caps

Purpose In patients with multiple myeloma, characterizing adherence to orally administered therapies, such as lenalidomide, is critical given their frequent use and potential for poorer outcomes associated with nonadherence. However, little data exist using prospective measures of adherence in this population. Our study piloted use of Medication Event Monitoring System (MEMS) caps and the patient-reported Brief Adherence Rating Scale (BARS) for 3 months in older adults with multiple myeloma. Methods We enrolled 13 patients with multiple myeloma receiving lenalidomide. Baseline characteristics were summarized; mean adherence to lenalidomide was reported with 95% confidence intervals. Results The median follow-up was 84 days. Of the 12 participants evaluable, median adherence, as assessed by the MEMS cap data, was 98%. Only 5 had 100% adherence. Deviations from intended use included missed prescribed doses made up during scheduled off week, additional days off between cycles, or taking fewer than anticipated days off. None of these events evident in MEMS data were self-disclosed. The mean difference in adherence estimated between the BARS and MEMS caps was 2%. Conclusion In this small sample, the observed adherence was higher than reported in retrospective studies using Medication Possession Ratio as a proxy for adherence. The BARS can be easily integrated into clinical encounters but has potential for reporting bias. MEMS caps can help characterize patterns of nonadherence, though there are limitations to their utility and the data can require thorough manual review to reconcile suspected occurrences of nonadherence. Studies should use more than 1 complementary measure of adherence. [Clinicaltrials.gov][1] ID: [NCT03779555][2], Registered 12/19/2018 ### Competing Interest Statement Wildes: Research funding: Janssen; Honoraria/advisory board fees: Sanofi, Seattle Genetics; consulting: Carevive systems. Mian: honoraria/advisory board fees: Takeda, Celgene/BMS, Forus, Pfizer, Janssen, GSK, Sanofi, Amgen and Research Funding: Janssen ### Funding Statement Support: Research reported in this publication was supported in part by the National Cancer Institute of the National Institutes of Health under the Award Number: UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant). . We would like to thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Missouri, for the use of the Clinical Trials Core which provided protocol development services. The Siteman Cancer Center is supported in part by an NCI Cancer Center Support Grant #P30 CA91842. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Institutional Review Board of Washington University School of Medicine gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: http://Clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03779555&atom=%2Fmedrxiv%2Fearly%2F2022%2F05%2F31%2F2022.05.30.22275780.atom