<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/NCT03767257</url>
  </required_header>
  <id_info>
    <org_study_id>18-421</org_study_id>
    <nct_id>NCT03767257</nct_id>
  </id_info>
  <brief_title>A Study of Colesevelam for Lenalidomide-Associated Diarrhea</brief_title>
  <official_title>A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the safety of colesevelam and find out what effects, if&#xD;
      any, colesevelam has on lenalidomide associated diarrhea in participants with multiple&#xD;
      myeloma on lenalidomide maintenance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate the ability of colesevelam to improve lenalidomide-associated diarrhea in participants with multiple myeloma treated with lenalidomide maintenance. Diarrhea will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) grading. The primary end-point is improvement of diarrhea to grade 1 or better according to the CTCAE 5.0 scale by 4 weeks of treatment with colesevelam.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GI symptom assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Diarrhea</condition>
  <arm_group>
    <arm_group_label>Participants with Myeloma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colesevelam Pill</intervention_name>
    <description>For treatment with colesevelam, the starting dose will be 1250 mg (2 x 625 mg) with food which can be increased to 6 tablets max per day based on efficacy and tolerability. Coleveselam should not be taken within 4 hours before or after lenalidomide and other interacting medications. All participants will be given a pill diary to record intake of colesevelam. The effect of colesevelam on lenalidomide-associated diarrhea will be evaluated after 1, 2, 4, 12 weeks after start of treatment. If the diarrhea does not respond to the starting dose of colesevelam, the dose can be increased every 2 days to 2 tablets two times per day (2 x 625 mg BID) and later to 3 tablets two times per day (3 x 625 mg BID). The colesevelam dose can be decrease to 1 tablet per day if there has been improvement of diarrhea but emergence of side effects.</description>
    <arm_group_label>Participants with Myeloma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Memorial Sloan Kettering Cancer Center (MSK) confirmed diagnosis of multiple myeloma&#xD;
&#xD;
          -  Treatment with single agent lenalidomide maintenance&#xD;
&#xD;
          -  Patient must be &gt;/= 18 years of age at the time of informed consent&#xD;
&#xD;
          -  Experiencing grade 1 or more diarrhea according to the CTCAE 5.0 criteria for at least&#xD;
             4 out of 7 days preceding screening and study inclusion&#xD;
&#xD;
          -  Scheduled to receive lenalidomide maintenance cyles at MSK&#xD;
&#xD;
          -  Willingness and ability to comply with scheduled visits, treatment plan, laboratory&#xD;
             tests and other study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of bowel obstruction&#xD;
&#xD;
          -  Patients with serum triglyceride levels &gt;300 mg/dL&#xD;
&#xD;
          -  Patients wit history of hypertriglyceridemia-induced panreatitis&#xD;
&#xD;
          -  Patients with known hypersensitivity to colesevelam or any component to the&#xD;
             formulation&#xD;
&#xD;
          -  Patients currently already receiving a bile acid sequestrant or have previously used&#xD;
             bile acid sequestrant drugs for diarrhea and had no benefit&#xD;
&#xD;
          -  Patients with diarrhea secondary to infection. Stool studies for GI pathogens should&#xD;
             be collected prior to starting colesevelam but do not need to be resulted prior to&#xD;
             starting Day 1 dose of colesevelam, unless infection is suspected by the treating&#xD;
             investigator, in which case (Clostridium difficile PCR when clinically indicated, GI&#xD;
             pathogen panel, stool ova and parasites, Giardia and Cryptosporum stool antigen tests&#xD;
             will need to be resulted at investigator discretion.)&#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>Malin Hultcrantz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (All Protocol Activities)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (All Protocol Activities)</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 Cancer Center @ Suffolk - Commack (All Protocol Activities)</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 (All Protocol Activities)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</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 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</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>Lenalidomide Associated Diarrhea</keyword>
  <keyword>Colesevelam</keyword>
  <keyword>18-421</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colesevelam Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03767257
org study id: 18-421
nct id: NCT03767257
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to test the safety of colesevelam and find out what effects, if
      any, colesevelam has on lenalidomide associated diarrhea in participants with multiple
      myeloma on lenalidomide maintenance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0
time frame: 4 weeks
description: To evaluate the ability of colesevelam to improve lenalidomide-associated diarrhea in participants with multiple myeloma treated with lenalidomide maintenance. Diarrhea will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) grading. The primary end-point is improvement of diarrhea to grade 1 or better according to the CTCAE 5.0 scale by 4 weeks of treatment with colesevelam.
measure: GI symptom assessment
time frame: 4 weeks
description: To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
arm group label: Participants with Myeloma
arm group type: Experimental
description: Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
intervention type: Drug
intervention name: Colesevelam Pill
description: For treatment with colesevelam, the starting dose will be 1250 mg (2 x 625 mg) with food which can be increased to 6 tablets max per day based on efficacy and tolerability. Coleveselam should not be taken within 4 hours before or after lenalidomide and other interacting medications. All participants will be given a pill diary to record intake of colesevelam. The effect of colesevelam on lenalidomide-associated diarrhea will be evaluated after 1, 2, 4, 12 weeks after start of treatment. If the diarrhea does not respond to the starting dose of colesevelam, the dose can be increased every 2 days to 2 tablets two times per day (2 x 625 mg BID) and later to 3 tablets two times per day (3 x 625 mg BID). The colesevelam dose can be decrease to 1 tablet per day if there has been improvement of diarrhea but emergence of side effects.
arm group label: Participants with Myeloma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malin Hultcrantz, MD, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
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: Diarrhea
mesh term: Colesevelam Hydrochloride
sharing ipd: Undecided