xml: <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/NCT05986682</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00110976</org_study_id>
      <secondary_id>218855</secondary_id>
      <nct_id>NCT05986682</nct_id>
    </id_info>
    <brief_title>Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma</brief_title>
    <official_title>Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</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>
        The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf&#xD;
        (BLENREP) and associated patterns of care, including dosing and dose modification, eye care&#xD;
        specialist visits, associated healthcare utilization, and clinical outcomes in patients with&#xD;
        relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI)&#xD;
        clinics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment characteristics of BLENREP therapy</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Treatment use and treatment patterns (dose, length of treatment, delays and dose reductions, reasons for discontinuation) will be summarized using proportions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment characteristics: Dosing patterns - Delays in treatment with BLENREP therapy</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment characteristics: Dosing patterns - Dose reductions during treatment with BLENREP therapy</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment characteristics: Duration of treatment with BLENREP</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Time (number of days) elapsed from treatment initiation with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation[SD]) and median (with interquartile range [IQR]) will be used to summarize duration across participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment characteristics: Number of cycles of treatment with BLENREP</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Number of cycles of treatment with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation[SD]) and median (with interquartile range [IQR]) will be used to summarize duration across participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment characteristics: Discontinuation of BLENREP treatment</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Number of participants who discontinued treatment with BLENREP by reason.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical outcomes: Overall Survival (OS)</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>The time from the start of BLENREP treatment until death, with censoring of participants who were alive when last seen or who were lost to follow up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical outcomes: Overall Response Rate (ORR)</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>The percentage of participants with the best overall response: partial response (PR), very good partial response (VFPR), compete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group [IMWG] response criteria (if available) or clinician assessment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical outcomes: Progression-Free Survival (PFS)</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical outcomes: Time To Response</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>The time from the start of BLENREP treatment to the date of first occurrence of response.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical outcomes: Duration of Response</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ophthalmology visits</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>a. The number of eye exam visits during BLENREP treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ophthalmology: Presence of Ocular toxicity</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Number of participants with specific ocular adverse events of interest (e.g. keratopathy) during treatment with BLENREP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ophthalmology: Treatments for Ocular toxicity</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Magnitude of distress using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Distress is measured on a scale of 0-10 on the NCCN DT. The main outcome variable is the occurrence of actionable distress, defined as a NCCN DT score of 4 or higher. The analysis will describe the proportion of clinic visits where actionable distress is reported during treatment with BLENREP, and the frequency of actionable distress over time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sources of distress using NCCN DT</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>Sources of distress will be assessed using the NCCN DT Problem List by examining the proportion of visits where types of problems are reported (e.g., physical or emotional problems). The frequency of individual types of problems, and the most commonly-reported problems will be examined descriptively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare resource utilization (HCRU)</measure>
      <time_frame>Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)</time_frame>
      <description>To the extent that they are available, HCRU (i.e., inpatient admissions, treatment-related outpatient visits, and emergency department visits) will be summarized by the mean (± SD) and median (with IQR) number of events per patient per year and by the proportion and frequency distribution of patients with any occurrence of the respective outcome. Likewise, mean (± SD) and median (with IQR) length of stay per year will be summarized for inpatient visits.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Multiple Myeloma</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Blenrep</intervention_name>
      <description>Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will analyze clinical data from adult patients with RRMM who were seen in the DCI&#xD;
          outpatient oncology clinics between August 5, 2020 and July 17, 2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years of age as of start of treatment with BLENREP&#xD;
  &#xD;
            -  Patients with a corresponding diagnosis code consistent with multiple myeloma seen at&#xD;
               Duke.&#xD;
  &#xD;
            -  Patients with a record of treatment with BLENREP for RRMM between August 5, 2020 and&#xD;
               July 17,2023.&#xD;
  &#xD;
            -  Patients having healthcare encounters at Duke Cancer Institute (DCI) for at least&#xD;
               1-month after start of Blenrep treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who were included in any clinical trial for BLENREP including expanded access&#xD;
               clinical trials&#xD;
  &#xD;
            -  Age &gt; 89 years of age as of start of index therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Thomas W LeBlanc, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thomas W LeBlanc, MD</last_name>
      <phone>919-668-2115</phone>
      <email>thomas.leblanc@duke.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27705</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Thomas W LeBlanc, MD</last_name>
        <phone>919-668-2115</phone>
        <email>thomas.leblanc@duke.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Relapsed</keyword>
    <keyword>Refractory</keyword>
    <keyword>Ophthalmology</keyword>
    <keyword>Keratopathy</keyword>
    <keyword>Distress</keyword>
    <keyword>NCCN Distress Thermometer</keyword>
    <keyword>Retrospective</keyword>
    <keyword>Patient Reported Outcomes</keyword>
    <keyword>Belantamab Mafodotin</keyword>
    <keyword>BLENREP</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986682
  org study id: Pro00110976
  secondary id: 218855
  nct id: NCT05986682
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf
        (BLENREP) and associated patterns of care, including dosing and dose modification, eye care
        specialist visits, associated healthcare utilization, and clinical outcomes in patients with
        relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI)
        clinics.
  observational model: Cohort
  time perspective: Retrospective
  measure: Treatment characteristics of BLENREP therapy
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Treatment use and treatment patterns (dose, length of treatment, delays and dose reductions, reasons for discontinuation) will be summarized using proportions.
  measure: Treatment characteristics: Dosing patterns - Delays in treatment with BLENREP therapy
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.
  measure: Treatment characteristics: Dosing patterns - Dose reductions during treatment with BLENREP therapy
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.
  measure: Treatment characteristics: Duration of treatment with BLENREP
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Time (number of days) elapsed from treatment initiation with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation[SD]) and median (with interquartile range [IQR]) will be used to summarize duration across participants.
  measure: Treatment characteristics: Number of cycles of treatment with BLENREP
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Number of cycles of treatment with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation[SD]) and median (with interquartile range [IQR]) will be used to summarize duration across participants.
  measure: Treatment characteristics: Discontinuation of BLENREP treatment
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Number of participants who discontinued treatment with BLENREP by reason.
  measure: Clinical outcomes: Overall Survival (OS)
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: The time from the start of BLENREP treatment until death, with censoring of participants who were alive when last seen or who were lost to follow up.
  measure: Clinical outcomes: Overall Response Rate (ORR)
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: The percentage of participants with the best overall response: partial response (PR), very good partial response (VFPR), compete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group [IMWG] response criteria (if available) or clinician assessment.
  measure: Clinical outcomes: Progression-Free Survival (PFS)
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.
  measure: Clinical outcomes: Time To Response
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: The time from the start of BLENREP treatment to the date of first occurrence of response.
  measure: Clinical outcomes: Duration of Response
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.
  measure: Ophthalmology visits
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: a. The number of eye exam visits during BLENREP treatment.
  measure: Ophthalmology: Presence of Ocular toxicity
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Number of participants with specific ocular adverse events of interest (e.g. keratopathy) during treatment with BLENREP
  measure: Ophthalmology: Treatments for Ocular toxicity
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.
  measure: Magnitude of distress using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Distress is measured on a scale of 0-10 on the NCCN DT. The main outcome variable is the occurrence of actionable distress, defined as a NCCN DT score of 4 or higher. The analysis will describe the proportion of clinic visits where actionable distress is reported during treatment with BLENREP, and the frequency of actionable distress over time.
  measure: Sources of distress using NCCN DT
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: Sources of distress will be assessed using the NCCN DT Problem List by examining the proportion of visits where types of problems are reported (e.g., physical or emotional problems). The frequency of individual types of problems, and the most commonly-reported problems will be examined descriptively.
  measure: Healthcare resource utilization (HCRU)
  time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe (July 17, 2023)
  description: To the extent that they are available, HCRU (i.e., inpatient admissions, treatment-related outpatient visits, and emergency department visits) will be summarized by the mean (± SD) and median (with IQR) number of events per patient per year and by the proportion and frequency distribution of patients with any occurrence of the respective outcome. Likewise, mean (± SD) and median (with IQR) length of stay per year will be summarized for inpatient visits.
  intervention type: Drug
  intervention name: Blenrep
  description: Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 89 Years
  last name: Thomas W LeBlanc, MD
  role: Principal Investigator
  affiliation: Duke University
  last name: Thomas W LeBlanc, MD
  phone: 919-668-2115
  email: thomas.leblanc@duke.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: No