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Lenalidomide Adherence in Older Adults

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ClinicalTrials.gov Identifier: NCT03779555
Recruitment Status : Terminated (Principal Investigator left the university)
First Posted : December 19, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: Medication Event Monitoring System

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma
Actual Study Start Date : December 13, 2019
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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 Name: MEMS




Primary Outcome Measures :
  1. Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open [ Time Frame: Through completion of study (estimated to be 3 months) ]
    -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


Secondary Outcome Measures :
  1. Adherence rate as measured by a modified Brief Adherence Rating Scale [ Time Frame: Through completion of study (estimated to be 3 months) ]
    • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who are taking lenalidomide.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779555


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Alliance for Clinical Trials in Oncology
Investigators
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Principal Investigator: Mark A Fiala, MSW Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03779555    
Other Study ID Numbers: 201812141
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases