<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/NCT03763370</url>
  </required_header>
  <id_info>
    <org_study_id>209233</org_study_id>
    <nct_id>NCT03763370</nct_id>
  </id_info>
  <brief_title>Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma</brief_title>
  <official_title>Expanded Access Program for Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma Who Are Refractory to a Proteasome Inhibitor, and an Immunomodulatory Agent, and an Anti-CD38 Antibody</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with&#xD;
      refractory/relapsing multiple myeloma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds&#xD;
      specifically to B-Cell Maturation Antigen. This program is intended to provide access to&#xD;
      belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are&#xD;
      refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an&#xD;
      immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome&#xD;
      inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). Patients considering this access&#xD;
      program should have no other therapeutic option, and not eligible for other clinical trials.&#xD;
      US patients who have been treated through the REMS program are eligible to enroll in this&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Multiple Myeloma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate</intervention_name>
    <description>Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Individual Patient IND:&#xD;
&#xD;
        INCLUSION CRITERIA:&#xD;
&#xD;
          1. Written informed consent&#xD;
&#xD;
          2. Diagnosis of RRMM and/or plasma cell dyscrasias and:&#xD;
&#xD;
               1. Has failed 4 prior therapies&#xD;
&#xD;
               2. Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38&#xD;
                  antibody (alone or in combinations if available)&#xD;
&#xD;
          3. Disease Progression on last therapy&#xD;
&#xD;
          4. Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment&#xD;
             cycles and as clinically indicated&#xD;
&#xD;
          5. Contraception requirements&#xD;
&#xD;
        A. Female Participants: A female patient is eligible to participate if one of the following&#xD;
        conditions applies:&#xD;
&#xD;
        I. The patient Is not a woman of childbearing potential (WOCBP)OR II. The patient Is a&#xD;
        WOCBP and using an effective contraceptive method during treatment with belantamab&#xD;
        mafodotin and for 4 months after the last dose. The patient must also have a negative&#xD;
        highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Please discuss&#xD;
        with GSK physician if the patient is pregnant, breast-feeding or planning to have a baby.&#xD;
&#xD;
        B. Male participants with female partners of child-bearing potential are eligible to&#xD;
        participate if they agree to use effective contraception during treatment with belantamab&#xD;
        mafodotin until 6 months after the last dose&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Evidence of Active Bleeding&#xD;
&#xD;
          2. Currently Active GVHD&#xD;
&#xD;
          3. Known Hypersensitivity to the active substance or to any of the excipients&#xD;
&#xD;
          4. Previous progression on belantamab mafodotin&#xD;
&#xD;
        US Expanded Access (group) Protocol:&#xD;
&#xD;
        INCLUSION CRITERIA:&#xD;
&#xD;
        For patients currently receiving BLENREP through the REMS program&#xD;
&#xD;
          1. Patients currently enrolled in the BLENREP REMS program who have received at least 1&#xD;
             dose of BLENREP&#xD;
&#xD;
          2. Written informed consent can be obtained from the patient or legally authorized&#xD;
             representative as per local regulations&#xD;
&#xD;
             For new patients&#xD;
&#xD;
          3. New patients diagnosed with RRMM who have received at least 4 prior therapies,&#xD;
             including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an&#xD;
             immunomodulatory agent&#xD;
&#xD;
          4. No other treatment options available&#xD;
&#xD;
          5. Written informed consent can be obtained from the patient or legally authorized&#xD;
             representative as per local regulations&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        For patients currently receiving BLENREP through the REMS program&#xD;
&#xD;
          1. Previously progressed on treatment with belantamab mafodotin.&#xD;
&#xD;
          2. Patient is pregnant or breastfeeding&#xD;
&#xD;
        For new patients&#xD;
&#xD;
          1. Previously progressed on treatment with belantamab mafodotin.&#xD;
&#xD;
          2. Patient is pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>US GSK Clinical Trials Call Center</last_name>
    <phone>877-379-3718</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact>
  <link>
    <url>http://gsk-cu-portal.idea-point.com</url>
    <description>If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal.</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>213304</keyword>
  <keyword>belantamab mafodotin</keyword>
  <keyword>Expanded Access Program</keyword>
  <keyword>Multiple Myeloma</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoconjugates</mesh_term>
  </intervention_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/NCT03763370
org study id: 209233
nct id: NCT03763370
lead sponsor: 
Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with
      refractory/relapsing multiple myeloma
Belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds
      specifically to B-Cell Maturation Antigen. This program is intended to provide access to
      belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are
      refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an
      immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome
      inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). Patients considering this access
      program should have no other therapeutic option, and not eligible for other clinical trials.
      US patients who have been treated through the REMS program are eligible to enroll in this
      program.
expanded access type individual: Yes
expanded access type treatment: Yes
intervention type: Drug
intervention name: Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate
description: Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
last name: US GSK Clinical Trials Call Center
phone: 877-379-3718
email: GSKClinicalSupportHD@gsk.com
url: http://gsk-cu-portal.idea-point.com
description: If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal.
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Immunoconjugates