<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/NCT03793907</url>
  </required_header>
  <id_info>
    <org_study_id>i 70118</org_study_id>
    <secondary_id>i 70118</secondary_id>
    <nct_id>NCT03793907</nct_id>
  </id_info>
  <brief_title>Strength Training in Improving Pain and Quality of Life in Patients With Multiple Myeloma</brief_title>
  <official_title>Feasibility of Strength Training and Impact on Pain and Quality of Life in Patients With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well strength training works in improving bone health, pain, and&#xD;
      quality of life in patients with multiple myeloma. Weekly physical activity may improve bone&#xD;
      recovery, reduce pain, and increase quality of life in patients with multiple myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        -  I. To assess the feasibility of a 6 month, twice weekly supervised strength training&#xD;
           intervention in patients with multiple myeloma. (Cohort 1)&#xD;
&#xD;
        -  II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase&#xD;
           in weekly physical activity in patient with multiple myeloma. (Cohort 2)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the adherence rate of patients during a 6 month intervention program.&#xD;
&#xD;
      II. To assess the eligibility and recruitment rate for the trial among patients with multiple&#xD;
      myeloma.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. Comparison of disease activity parameters, physical activity level, clinical symptoms,&#xD;
      medication, psycho-oncological parameters before, during and after intervention.&#xD;
&#xD;
      II. Determine factors that may influence a persons' willingness to participate in the trial.&#xD;
&#xD;
      III. Investigate &quot;immune fitness&quot; by frequencies and function of immune cell subsets in&#xD;
      peripheral blood.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 cohorts.&#xD;
&#xD;
      COHRT 1 (STRENGTH TRAINING): Patients receive a Fitbit to track their physical activity, and&#xD;
      complete an in-person personalized and supervised full-body strength training program over 1&#xD;
      hour twice weekly (BID) up to 52 sessions for 6 months.&#xD;
&#xD;
      COHORT 2 (BEHAVIORAL INTERVENTION): Patients receive a Fitbit to track their physical&#xD;
      activity, and complete an unsupervised walking program daily at home, increasing physical&#xD;
      activity stepwise weekly, for 6 months.&#xD;
&#xD;
      After completion of study, patients are followed up every 3 months for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2019</start_date>
  <completion_date type="Actual">November 10, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility rate</measure>
    <time_frame>At 6 months</time_frame>
    <description>Will be defined as the proportion of enrolled patients who are still on study at the end of 6 months. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence rate (Cohort 1)</measure>
    <time_frame>At 6 months</time_frame>
    <description>Will be defined as the proportion of patients remaining on study at 6 months who complete &gt;= 80% of the intervention activities. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence rate (Cohort 2)</measure>
    <time_frame>At 6 months</time_frame>
    <description>Will be defined as the proportion of patients whose average daily step counts each week are at or above their goal for that week at least 20/26 weeks, or 80% of the weeks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Differences in lab parameters</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical performance</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity level</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Polyneuropathy</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Opioid and other drug consumption</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Psycho-oncological parameters</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue</measure>
    <time_frame>Before, during and after strength training program</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Reasons why patients do not participate in the trial</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist.</description>
  </other_outcome>
  <other_outcome>
    <measure>&quot;Immune fitness&quot; frequencies and function of immune cell subsets</measure>
    <time_frame>Before and after strength training program up to 1 year</time_frame>
    <description>Will be measured in peripheral blood. Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Plasma Cell Myeloma</condition>
  <arm_group>
    <arm_group_label>Cohort 2 (walking program)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 (strength training)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour BID up to 52 sessions for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FitBit</intervention_name>
    <description>Wear Fitbit</description>
    <arm_group_label>Cohort 1 (strength training)</arm_group_label>
    <arm_group_label>Cohort 2 (walking program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Cohort 1 (strength training)</arm_group_label>
    <arm_group_label>Cohort 2 (walking program)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Cohort 1 (strength training)</arm_group_label>
    <arm_group_label>Cohort 2 (walking program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <description>Complete strength training</description>
    <arm_group_label>Cohort 1 (strength training)</arm_group_label>
    <other_name>Strength Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STEPS to Enhance Physical Activity</intervention_name>
    <description>Complete a walking program</description>
    <arm_group_label>Cohort 2 (walking program)</arm_group_label>
    <other_name>STEPS</other_name>
    <other_name>STEPS Intervention</other_name>
    <other_name>STEPS to Enhance Physical Activity (STEPS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1&#xD;
&#xD;
          -  Have a diagnosis of multiple myeloma&#xD;
&#xD;
          -  Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would&#xD;
             put them in danger when participating in the study according to the physician's&#xD;
             discretion&#xD;
&#xD;
          -  Are able to understand and follow assessment and training procedures&#xD;
&#xD;
          -  Participant or legal representative must understand the investigational nature of this&#xD;
             study and sign an Independent Ethics Committee/Institutional Review Board approved&#xD;
             written informed consent form prior to receiving any study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current and symptomatic pathological fracture(s) or severely advanced instability of&#xD;
             the musculo-skeletal system&#xD;
&#xD;
          -  Acute bone instability as assessed by whole body low-dose computed tomography and&#xD;
             evaluated by an experienced neuro- and spine surgeon&#xD;
&#xD;
          -  Major comorbidities that would cause danger to the patient when participating in the&#xD;
             study. Examples are cardiac or pulmonary and infectious diseases that would have a&#xD;
             risk of progression if the patient took part in the study&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the participant an unsuitable&#xD;
             candidate to take part in study intervention (comorbidities, myeloma symptoms,&#xD;
             treatment side effects)&#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>Jens Hillengass</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</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>
  <!-- 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/NCT03793907
org study id: i 70118
secondary id: i 70118
nct id: NCT03793907
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial studies how well strength training works in improving bone health, pain, and
      quality of life in patients with multiple myeloma. Weekly physical activity may improve bone
      recovery, reduce pain, and increase quality of life in patients with multiple myeloma.
PRIMARY OBJECTIVES:

        -  I. To assess the feasibility of a 6 month, twice weekly supervised strength training
           intervention in patients with multiple myeloma. (Cohort 1)

        -  II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase
           in weekly physical activity in patient with multiple myeloma. (Cohort 2)

      SECONDARY OBJECTIVES:

      I. To assess the adherence rate of patients during a 6 month intervention program.

      II. To assess the eligibility and recruitment rate for the trial among patients with multiple
      myeloma.

      EXPLORATORY OBJECTIVES:

      I. Comparison of disease activity parameters, physical activity level, clinical symptoms,
      medication, psycho-oncological parameters before, during and after intervention.

      II. Determine factors that may influence a persons' willingness to participate in the trial.

      III. Investigate "immune fitness" by frequencies and function of immune cell subsets in
      peripheral blood.

      OUTLINE: Patients are assigned to 1 of 2 cohorts.

      COHRT 1 (STRENGTH TRAINING): Patients receive a Fitbit to track their physical activity, and
      complete an in-person personalized and supervised full-body strength training program over 1
      hour twice weekly (BID) up to 52 sessions for 6 months.

      COHORT 2 (BEHAVIORAL INTERVENTION): Patients receive a Fitbit to track their physical
      activity, and complete an unsupervised walking program daily at home, increasing physical
      activity stepwise weekly, for 6 months.

      After completion of study, patients are followed up every 3 months for 1 year.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility rate
time frame: At 6 months
description: Will be defined as the proportion of enrolled patients who are still on study at the end of 6 months. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method.
measure: Adherence rate (Cohort 1)
time frame: At 6 months
description: Will be defined as the proportion of patients remaining on study at 6 months who complete >= 80% of the intervention activities. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method.
measure: Adherence rate (Cohort 2)
time frame: At 6 months
description: Will be defined as the proportion of patients whose average daily step counts each week are at or above their goal for that week at least 20/26 weeks, or 80% of the weeks.
measure: Differences in lab parameters
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Clinical performance
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Physical activity level
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Pain
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Polyneuropathy
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Opioid and other drug consumption
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Psycho-oncological parameters
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Fatigue
time frame: Before, during and after strength training program
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments.
measure: Reasons why patients do not participate in the trial
time frame: Before and after strength training program up to 1 year
description: Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist.
measure: "Immune fitness" frequencies and function of immune cell subsets
time frame: Before and after strength training program up to 1 year
description: Will be measured in peripheral blood. Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist.
arm group label: Cohort 2 (walking program)
arm group type: Active Comparator
description: Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months.
arm group label: Cohort 1 (strength training)
arm group type: Experimental
description: Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour BID up to 52 sessions for 6 months.
intervention type: Device
intervention name: FitBit
description: Wear Fitbit
arm group label: Cohort 1 (strength training)
arm group label: Cohort 2 (walking program)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Cohort 1 (strength training)
arm group label: Cohort 2 (walking program)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Cohort 1 (strength training)
arm group label: Cohort 2 (walking program)
intervention type: Other
intervention name: Resistance Training
description: Complete strength training
arm group label: Cohort 1 (strength training)
other name: Strength Training
intervention type: Behavioral
intervention name: STEPS to Enhance Physical Activity
description: Complete a walking program
arm group label: Cohort 2 (walking program)
other name: STEPS
other name: STEPS Intervention
other name: STEPS to Enhance Physical Activity (STEPS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Hillengass
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell