<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/NCT03006315</url>
  </required_header>
  <id_info>
    <org_study_id>16-1662</org_study_id>
    <nct_id>NCT03006315</nct_id>
  </id_info>
  <brief_title>Mobile Health Device Study for Myeloma Patients</brief_title>
  <official_title>Bio-monitoring of Newly Diagnosed Multiple Myeloma Patients Receiving Induction Chemotherapy Using Mobile Wearable Health Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enrolled participants health status will be tracked by using a mobile health-monitoring&#xD;
      device while undergoing chemotherapy for multiple myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Newly diagnosed multiple myeloma participants receiving induction chemotherapy will be&#xD;
      continuously bio-monitored at baseline (1-7 days prior to treatment initiation) and during&#xD;
      induction chemotherapy up to completion of 6 cycles using the Garmin Vivofit wearable device.&#xD;
      For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post&#xD;
      ASCT. The study will include a total of 40 newly diagnosed multiple myeloma participants in&#xD;
      two cohorts with 20 patients in each cohort (Cohort A and B). Cohort A will be comprised of&#xD;
      patients &lt;65 years. Cohort B will be comprised of patients &gt;/= 65 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Number of patients continuously wearing the device.</measure>
    <time_frame>1 year</time_frame>
    <description>Feasibility of using mobile wearable health device</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Myeloma</condition>
  <arm_group>
    <arm_group_label>Cohort A: &lt;65 years</arm_group_label>
    <description>Cohort A will be comprised of participants &lt;65 years old and will accrue a total of 20 patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: &gt;/= 65 years</arm_group_label>
    <description>Cohort B will be comprised of participants &gt;/= 65 years and will accrue a total of 20 patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Garmin Vivofit device</intervention_name>
    <description>Participants will be bio-monitored using the Garmin Vivofit mobile wearable device at baseline (at least 1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT.</description>
    <arm_group_label>Cohort A: &lt;65 years</arm_group_label>
    <arm_group_label>Cohort B: &gt;/= 65 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Health quality of life assessements</intervention_name>
    <arm_group_label>Cohort A: &lt;65 years</arm_group_label>
    <arm_group_label>Cohort B: &gt;/= 65 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed Multiple Myeloma participants with clinical and histological confirmation&#xD;
        of diagnosis planning to receive chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Newly diagnosed Multiple Myeloma meeting International Myeloma Working Group (IMWG)&#xD;
        criteria (as below) participants with clinical and histological confirmation of diagnosis&#xD;
        planning to receive chemotherapy are eligible:&#xD;
&#xD;
          -  Newly diagnosed Multiple Myeloma patients will have evidence of underlying end organ&#xD;
             damage and/or myeloma defining event attributed to underlying plasma cell&#xD;
             proliferative disorder meeting at least one of the following:&#xD;
&#xD;
          -  Hypercalcemia: serum calcium &gt;0.25 mmol/L (&gt; 1 mg/dL) above upper limit of normal or ≥&#xD;
             2.75 mmol/L (11 mg/dL)&#xD;
&#xD;
          -  Anemia: hemoglobin value &lt;10 g/dL or &gt; 2 g/dL below lower limit of normal&#xD;
&#xD;
          -  Bone disease: ≥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients with 1&#xD;
             lytic lesion, bone marrow should demonstrate ≥ 10% clonal plasma cells&#xD;
&#xD;
          -  Clonal bone marrow plasma cell percentage ≥ 60%&#xD;
&#xD;
          -  Involved/un-involved serum free light chain ratio ≥100 and involved free light chain&#xD;
             &gt;100 mg/L&#xD;
&#xD;
          -  &gt; 1 focal lesion on magnetic resonance imaging study (lesion must be &gt;5 mm) in size&#xD;
&#xD;
          -  All study participants will be required to receive primary chemotherapy treatment at a&#xD;
             Memorial Sloan Kettering facility, including regional outpatient sites.&#xD;
&#xD;
          -  All study participants will be required to have a smart phone or tablet device&#xD;
             compatible with the Garmin Vivofit device.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Plasma cell leukemia&#xD;
&#xD;
          -  POEMS syndrome&#xD;
&#xD;
          -  Amyloidosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Korde, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiple myeloma</keyword>
  <keyword>garmin vivofit</keyword>
  <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>
  <!-- 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/NCT03006315
org study id: 16-1662
nct id: NCT03006315
lead sponsor: 
has dmc: No
Enrolled participants health status will be tracked by using a mobile health-monitoring
      device while undergoing chemotherapy for multiple myeloma.
Newly diagnosed multiple myeloma participants receiving induction chemotherapy will be
      continuously bio-monitored at baseline (1-7 days prior to treatment initiation) and during
      induction chemotherapy up to completion of 6 cycles using the Garmin Vivofit wearable device.
      For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post
      ASCT. The study will include a total of 40 newly diagnosed multiple myeloma participants in
      two cohorts with 20 patients in each cohort (Cohort A and B). Cohort A will be comprised of
      patients <65 years. Cohort B will be comprised of patients >/= 65 years.
observational model: Cohort
time perspective: Prospective
measure: Number of patients continuously wearing the device.
time frame: 1 year
description: Feasibility of using mobile wearable health device
arm group label: Cohort A: <65 years
description: Cohort A will be comprised of participants <65 years old and will accrue a total of 20 patients.
arm group label: Cohort B: >/= 65 years
description: Cohort B will be comprised of participants >/= 65 years and will accrue a total of 20 patients.
intervention type: Device
intervention name: Garmin Vivofit device
description: Participants will be bio-monitored using the Garmin Vivofit mobile wearable device at baseline (at least 1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT.
arm group label: Cohort A: <65 years
arm group label: Cohort B: >/= 65 years
intervention type: Behavioral
intervention name: Mobile Health quality of life assessements
arm group label: Cohort A: <65 years
arm group label: Cohort B: >/= 65 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neha Korde, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell