Lenalidomide Adherence in Older Adults

Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma

To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Medication Event Monitoring System

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who are taking lenalidomide.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: Medication Event Monitoring System; -Microchipped bottle cap; Other Names: MEMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate as measured by a modified Brief Adherence Rating Scale	Participants will fill out a brief survey about taking lenalidomide and an estimate of their adherence using a visual analog scale; Scored 0-100%, 0% = lenalidomide not taken on any days and 100% = lenalidomide taken every day	Through completion of study (estimated to be 3 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Alliance for Clinical Trials in Oncology
• Investigators: Principal Investigator: Mark A Fiala, MSW, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 201812141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No