<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779555</url>
  </required_header>
  <id_info>
    <org_study_id>201812141</org_study_id>
    <nct_id>NCT03779555</nct_id>
  </id_info>
  <brief_title>Lenalidomide Adherence in Older Adults</brief_title>
  <official_title>Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To describe patterns of adherence and pilot baseline measures to investigate factors&#xD;
      associated with lower adherence to lenalidomide in older adults with myeloma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator left the university&#xD;
  </why_stopped>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open</measure>
    <time_frame>Through completion of study (estimated to be 3 months)</time_frame>
    <description>-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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence rate as measured by a modified Brief Adherence Rating Scale</measure>
    <time_frame>Through completion of study (estimated to be 3 months)</time_frame>
    <description>Participants will fill out a brief survey about taking lenalidomide and an estimate of their adherence using a visual analog scale&#xD;
Scored 0-100%, 0% = lenalidomide not taken on any days and 100% = lenalidomide taken every day</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Patients taking lenalidomide for multiple myeloma</arm_group_label>
    <description>-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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication Event Monitoring System</intervention_name>
    <description>-Microchipped bottle cap</description>
    <arm_group_label>Patients taking lenalidomide for multiple myeloma</arm_group_label>
    <other_name>MEMS</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who&#xD;
        are taking lenalidomide.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥65&#xD;
&#xD;
          -  Receiving lenalidomide for treatment of multiple myeloma.&#xD;
&#xD;
          -  Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites&#xD;
&#xD;
          -  Able to read and understand English.&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
             document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Estimated life expectancy &lt;6 months.&#xD;
&#xD;
          -  Anticipated duration of lenalidomide therapy &lt;3 months.&#xD;
&#xD;
          -  Residing in a nursing facility where their medications are administered to them OR&#xD;
             patient reports they do not self-administer their own medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark A Fiala, MSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779555
org study id: 201812141
nct id: NCT03779555
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To describe patterns of adherence and pilot baseline measures to investigate factors
      associated with lower adherence to lenalidomide in older adults with myeloma.
observational model: Cohort
time perspective: Prospective
measure: 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)
description: -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
measure: Adherence rate as measured by a modified Brief Adherence Rating Scale
time frame: Through completion of study (estimated to be 3 months)
description: 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
arm group label: Patients taking lenalidomide for multiple myeloma
description: -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)
intervention type: Other
intervention name: Medication Event Monitoring System
description: -Microchipped bottle cap
arm group label: Patients taking lenalidomide for multiple myeloma
other name: MEMS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Mark A Fiala, MSW
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No