Study Stopped
Principal Investigator left the university
Lenalidomide Adherence in Older Adults
1 other identifier
observational
17
1 country
1
Brief Summary
To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedOctober 22, 2020
October 1, 2020
9 months
December 17, 2018
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open
-Participants will be given a pill diary in which they will record if they opened the pill bottle without taking a medication (e.g. to ascertain remaining supply) to adjust the adherence rate accordingly
Through completion of study (estimated to be 3 months)
Secondary Outcomes (1)
Adherence rate as measured by a modified Brief Adherence Rating Scale
Through completion of study (estimated to be 3 months)
Study Arms (1)
Patients taking lenalidomide for multiple myeloma
-Patients will be seen at baseline, 1 month (+/- 1 week), 2 months (3-5 weeks following 1-month assessment), and 3 months (3-5 weeks after 2-month follow-up)
Interventions
-Microchipped bottle cap
Eligibility Criteria
Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who are taking lenalidomide.
You may qualify if:
- Age ≥65
- Receiving lenalidomide for treatment of multiple myeloma.
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Able to read and understand English.
- Able to understand and willing to sign an IRB-approved written informed consent document.
You may not qualify if:
- Estimated life expectancy \<6 months.
- Anticipated duration of lenalidomide therapy \<3 months.
- Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Silberstein AE, Fiala MA, Loh KP, Cordner T, Mian H, Wildes TM. A pilot study of adherence to lenalidomide among older patients with multiple myeloma. J Geriatr Oncol. 2023 Sep;14(7):101560. doi: 10.1016/j.jgo.2023.101560. Epub 2023 Jun 27. No abstract available.
PMID: 37380519DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Fiala, MSW
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2018
First Posted
December 19, 2018
Study Start
December 13, 2019
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share