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NCT03779555 Clinical Trial

Lenalidomide Adherence in Older Adults

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03779555
Other study ID # 201812141
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 13, 2019
Est. completion date August 31, 2020

Study information
Verified date October 2020
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Medication Event Monitoring System
-Microchipped bottle cap

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Washington University School of Medicine Alliance for Clinical Trials in Oncology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
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Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

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