<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/NCT04484623</url>
  </required_header>
  <id_info>
    <org_study_id>207499</org_study_id>
    <secondary_id>2018-004354-21</secondary_id>
    <nct_id>NCT04484623</nct_id>
  </id_info>
  <brief_title>Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma</brief_title>
  <acronym>DREAMM 8</acronym>
  <official_title>A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of belantamab mafodotin in combination with&#xD;
      pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide,&#xD;
      bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple&#xD;
      myeloma (RRMM).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 28, 2027</completion_date>
  <primary_completion_date type="Anticipated">October 3, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>PFS will be defined as the time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. The primary analysis of PFS will be based on Independent Review Committee (IRC) assessed response and dates per International Myeloma Working Group (IMWG) criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>DoR will be defined as the time from first documented evidence of partial response or better until progressive disease (PD) or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal residual disease (MRD) negativity rate</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>MRD negativity rate will be defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing (NGS) at 10^5 threshold) at least once during the time of confirmed CR or better response, according to IMWG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>OS will be defined as the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>ORR will be defined as the percentage of participants with a confirmed partial response or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate (CRR)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>CRR will be defined as the percentage of participants with a confirmed complete response or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very good partial response (VGPR) or better rate</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>VGPR will be the defined as the percentage of participants with a confirmed VGPR or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to best response (TTBR)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>TTBR will be defined as the time from the start of study treatment to the first documented evidence of best response among participants who achieve partial response or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response (TTR)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>TTR will be defined as the time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>TTP will be defined as the time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival on subsequent line of therapy (PFS2)</measure>
    <time_frame>Up to 84 months</time_frame>
    <description>PFS2 will be defined as the time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (AEs) and serious adverse events (SAEs)</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal ocular findings on ophthalmic examination</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of belantamab mafodotin at indicated time points</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax) for pomalidomide</measure>
    <time_frame>Up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Cmax (Tmax) for pomalidomide</measure>
    <time_frame>Up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for pomalidomide</measure>
    <time_frame>Up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Titers of ADAs against belantamab mafodotin</measure>
    <time_frame>Up to 84 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with maximum post-baseline changes in patient-reported outcome version of the common terminology criteria for adverse events (PRO-CTCAE) scores for each item attribute</measure>
    <time_frame>Baseline and up to 84 months</time_frame>
    <description>PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)</measure>
    <time_frame>Baseline and up to 84 months</time_frame>
    <description>EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in HRQoL as measured by EORTC item library 52 (IL52)</measure>
    <time_frame>Baseline and up to 84 months</time_frame>
    <description>EORTC QLQ- 20-item Multiple Myeloma Module (MY20) questionnaire will be referred to as the EORTC IL52. Only disease symptoms domain will be assessed. A high score represents a high level of symptoms or problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in HRQoL as measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20)</measure>
    <time_frame>Baseline and up to 84 months</time_frame>
    <description>EORTC QLQ-MY20 is a questionnaire which will evaluate disease symptoms. In EORTC QLQ-MY20, domain scores will be averaged and will be transformed linearly to a score ranging from 0 to 100. Higher score represents high level of symptomatology or problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Bortezomib plus Pomalidomide and Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Belantamab mafodotin</intervention_name>
    <description>Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.</description>
    <arm_group_label>Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Immunomodulatory imide drug (IMiD) will be administered.</description>
    <arm_group_label>Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone</arm_group_label>
    <arm_group_label>Arm B: Bortezomib plus Pomalidomide and Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Synthetic glucocorticoid with anti-tumor activity will be administered.</description>
    <arm_group_label>Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone</arm_group_label>
    <arm_group_label>Arm B: Bortezomib plus Pomalidomide and Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib</intervention_name>
    <description>Proteasome Inhibitor will be administered.</description>
    <arm_group_label>Arm B: Bortezomib plus Pomalidomide and Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
          -  Male or female, 18 years or older.&#xD;
&#xD;
          -  Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International&#xD;
             Myeloma Working Group (IMWG) criteria.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
&#xD;
          -  Have been previously treated with at least 1 prior line of MM therapy including a&#xD;
             lenalidomide-containing regimen and must have documented disease progression during or&#xD;
             after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily&#xD;
             for at least 2 consecutive cycles are eligible).&#xD;
&#xD;
          -  Must have at least 1 aspect of measurable disease defined as one of the following;&#xD;
&#xD;
               1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per&#xD;
                  24-hour, or&#xD;
&#xD;
               2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]), or&#xD;
&#xD;
               3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and&#xD;
                  an abnormal serum free light chain ratio (less than [&lt;]0.26 or greater than&#xD;
                  [&gt;]1.65) only if participant has no measurable urine or serum M spike.&#xD;
&#xD;
          -  Have undergone autologous stem cell transplant (ASCT) or are considered transplant&#xD;
             ineligible. Participants with a history of ASCT are eligible for study participation&#xD;
             provided the following eligibility criteria are met: a. ASCT was &gt;100 days prior to&#xD;
             the first dose of study medication. b. No active bacterial, viral, or fungal&#xD;
             infection(s) present&#xD;
&#xD;
          -  All prior treatment-related toxicities (defined by National Cancer Institute Common&#xD;
             Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or&#xD;
             equal to (≤)Grade 1 at the time of enrolment, except for alopecia.&#xD;
&#xD;
          -  Adequate organ system functions as mentioned in the protocol.&#xD;
&#xD;
          -  Male and female participants agree to abide by protocol-defined contraceptive&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy,&#xD;
             organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin&#xD;
             changes (POEMS) syndrome at the time of screening.&#xD;
&#xD;
          -  Prior allogeneic SCT.&#xD;
&#xD;
          -  Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14&#xD;
             days or five half-lives (whichever is shorter) preceding the first dose of study drug;&#xD;
             prior treatment with a monoclonal antibody drug within 30 days of receiving the first&#xD;
             dose of study drugs.&#xD;
&#xD;
          -  Plasmapheresis within 7 days prior to the first dose of study drug.&#xD;
&#xD;
          -  Received prior treatment with or intolerant to pomalidomide.&#xD;
&#xD;
          -  Received prior Beta cell maturation antigen (BCMA) targeted therapy.&#xD;
&#xD;
          -  Intolerant to bortezomib or refractory to bortezomib (for example; participant&#xD;
             experienced progressive disease during treatment, or within 60 days of completing&#xD;
             treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice&#xD;
             weekly).&#xD;
&#xD;
          -  Evidence of cardiovascular risk including any of the following;&#xD;
&#xD;
               1. Evidence of current clinically significant untreated arrhythmias, including&#xD;
                  clinically significant electrocardiogram abnormalities including second degree&#xD;
                  (Mobitz type II) or third degree atrioventricular (AV) block.&#xD;
&#xD;
               2. Recent history within (3 months of screening) of myocardial infarction, acute&#xD;
                  coronary syndromes (including unstable angina), coronary angioplasty, or stenting&#xD;
                  or bypass grafting .&#xD;
&#xD;
               3. Class III or IV heart failure as defined by the New York Heart Association (NYHA)&#xD;
                  functional classification system&#xD;
&#xD;
               4. Uncontrolled hypertension.&#xD;
&#xD;
          -  Any major surgery within the last 4 weeks.&#xD;
&#xD;
          -  Previous or concurrent invasive malignancy other than multiple myeloma, except:&#xD;
&#xD;
               1. The disease must be considered medically stable for at least 2 years; or&#xD;
&#xD;
               2. The participant must not be receiving active therapy, other than hormonal therapy&#xD;
                  for this disease.&#xD;
&#xD;
          -  Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to&#xD;
             belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of&#xD;
             the components of the study treatment.&#xD;
&#xD;
          -  Evidence of active mucosal or internal bleeding.&#xD;
&#xD;
          -  Cirrhosis or current unstable liver or biliary disease per investigator assessment&#xD;
             defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,&#xD;
             esophageal or gastric varices, persistent jaundice.&#xD;
&#xD;
          -  Active infection requiring treatment.&#xD;
&#xD;
          -  Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis&#xD;
             C will be excluded unless the protocol-defined criteria are met.&#xD;
&#xD;
          -  Presence of active renal conditions (such as infection, severe renal impairment&#xD;
             requiring dialysis or any other condition that could affect participant's safety).&#xD;
&#xD;
          -  Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization&#xD;
             or ≥Grade 3 peripheral neuropathy.&#xD;
&#xD;
          -  Active or history of venous and arterial thromboembolism within the past 3 months.&#xD;
&#xD;
          -  Contraindications to or unwilling to undergo protocol-required anti-thrombotic&#xD;
             prophylaxis.&#xD;
&#xD;
          -  Current corneal disease except for mild punctate keratopathy.&#xD;
&#xD;
          -  Any serious and/or unstable pre-existing medical, psychiatric disorder or other&#xD;
             conditions (including laboratory abnormalities) that could interfere with&#xD;
             participant's safety, obtaining informed consent or compliance to the study&#xD;
             procedures.&#xD;
&#xD;
          -  Pregnant or lactating female.&#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>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>
  <overall_contact_backup>
    <last_name>EU GSK Clinical Trials Call Center</last_name>
    <phone>+44 (0) 20 89904466</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Manuel R Modiano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Henning Schade</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Syed Farhan Zafar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Gustaro A Fonseca</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Isaac Levy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Danko Martincic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Clifton Mo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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    <investigator>
      <last_name>Edwin Lee</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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    <investigator>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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    <contact_backup>
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    <investigator>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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      <last_name>Huey-Shin Cindy Lee</last_name>
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    <status>Recruiting</status>
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    <contact_backup>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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    <contact_backup>
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      <name>GSK Investigational Site</name>
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        <city>Montreal</city>
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        <country>Canada</country>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Emilie Lemieux-Blanchard</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Guangzhou</city>
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        <zip>510060</zip>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Zhongjun Xia</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Shenzhen</city>
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        <zip>518029</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Xin Du</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Chunyan Sun</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Changsha</city>
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        <zip>410013</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Xin Li</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <state>Jiangsu</state>
        <zip>221004</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Zhiling Yan</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <zip>330006</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Fei Li</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Wei Yang</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <zip>100191</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Hongmei Jing</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Tianjin</city>
        <zip>300020</zip>
        <country>China</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Weiwei Sui</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Ludek Pour</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Jakub Radocha</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Praha 2</city>
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        <country>Czechia</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Ivan Spicka</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Dijon cedex</city>
        <zip>21079</zip>
        <country>France</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Denis Caillot</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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        <city>Marseille Cedex 9</city>
        <zip>13273</zip>
        <country>France</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Anne-Marie Stoppa</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Périgueux cedex</city>
        <zip>24019</zip>
        <country>France</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Claire Calmettes</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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        <zip>31059</zip>
        <country>France</country>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Aurore Perrot</last_name>
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  <location>
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        <zip>54500</zip>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Pierre Feugier</last_name>
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  <location>
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        <state>Baden-Wuerttemberg</state>
        <zip>69120</zip>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Marc Raab</last_name>
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  <location>
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        <zip>72076</zip>
        <country>Germany</country>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Britta Besemer</last_name>
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        <city>Wuerzburg</city>
        <state>Bayern</state>
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        <country>Germany</country>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Martin Kortuem</last_name>
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      <name>GSK Investigational Site</name>
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        <zip>55101</zip>
        <country>Germany</country>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Markus Munder</last_name>
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        <state>Sachsen</state>
        <zip>04103</zip>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <last_name>Song-Yau Wang</last_name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Taiga Kuroi</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Hideki Goto</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Iwate</city>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Shigeki Ito</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Toshiro Kawakita</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Junya Kuroda</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Kazutaka Sunami</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Michiko Ichii</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Yasuhito Terui</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Shuji Ozaki</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Yoichi Imai</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Kazuhito Suzuki</last_name>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Tetsuya Fukuda</last_name>
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  <location>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Kenichi Ishizawa</last_name>
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  <location>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Ho-Jin Shin</last_name>
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  <location>
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        <zip>10408</zip>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>HyeonSeok Eom</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
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        <zip>58128</zip>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Je-Jung Lee</last_name>
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  <location>
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        <zip>405-760</zip>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Jae Hoon Lee</last_name>
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  <location>
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        <zip>03722</zip>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Jin Seok Kim</last_name>
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  <location>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Kihyun Kim</last_name>
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  <location>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Chang Ki Min</last_name>
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  <location>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>JaMin Byun</last_name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Jae-Cheol Jo</last_name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Sharon Jackson</last_name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Merit Hanna</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Nicole Yu-Shan Chien</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Hugh Goodman</last_name>
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  <location>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <name>GSK Investigational Site</name>
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    <status>Recruiting</status>
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    <investigator>
      <last_name>Jaroslaw Czyz</last_name>
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  <location>
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    <contact_backup>
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  <location>
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    <contact_backup>
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    <investigator>
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  <location>
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    <contact_backup>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Tomasz Wrobel</last_name>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Elena Borisenkova</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Vladimir Ivanovich Vorobiev</last_name>
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  <location>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Sergey Semochkin</last_name>
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  <location>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Olga S. Uspenskaya</last_name>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
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    <status>Recruiting</status>
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    <contact_backup>
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    <investigator>
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    <contact_backup>
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    <investigator>
      <last_name>Jesús San Miguel Izquierdo</last_name>
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    <contact_backup>
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    <contact_backup>
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    <investigator>
      <last_name>Mercedes Gironella Mesa</last_name>
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    <contact_backup>
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    <investigator>
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    <contact_backup>
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        <zip>41013</zip>
        <country>Spain</country>
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    <investigator>
      <last_name>Estrella Carrillo Cruz</last_name>
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  </location>
  <location>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
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    <status>Recruiting</status>
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    <investigator>
      <last_name>Javier de la Rubia Comos</last_name>
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  <location>
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      <name>GSK Investigational Site</name>
      <address>
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    <status>Recruiting</status>
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      <last_name>Mehmet Sinan Dal</last_name>
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    <investigator>
      <last_name>Zubeyde Ozkurt</last_name>
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      <address>
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    <investigator>
      <last_name>Meral Beksac</last_name>
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  </location>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34214</zip>
        <country>Turkey</country>
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    <status>Recruiting</status>
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    <investigator>
      <last_name>Omur G Sevindik</last_name>
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      <name>GSK Investigational Site</name>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
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    <status>Recruiting</status>
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    <investigator>
      <last_name>Hayri Ozsan</last_name>
      <role>Principal Investigator</role>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kocaeli</city>
        <zip>41400</zip>
        <country>Turkey</country>
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    <status>Recruiting</status>
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    <investigator>
      <last_name>Zafer Gulbas</last_name>
      <role>Principal Investigator</role>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mersin</city>
        <zip>33343</zip>
        <country>Turkey</country>
      </address>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <investigator>
      <last_name>Anil Tombak</last_name>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Mehmet Turgut</last_name>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Matthew Jenner</last_name>
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  <location>
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      <address>
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        <state>Lanarkshire</state>
        <zip>ML6 0JS</zip>
        <country>United Kingdom</country>
      </address>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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    <contact_backup>
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    <investigator>
      <last_name>Iain Singer</last_name>
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  </location>
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    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stoke-on-Trent</city>
        <state>Staffordshire</state>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Kamaraj Karunanithi</last_name>
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      <name>GSK Investigational Site</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Kevin Boyd</last_name>
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      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
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    <status>Recruiting</status>
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      <last_name>US GSK Clinical Trials Call Center</last_name>
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      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Rachel Hall</last_name>
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      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
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    <investigator>
      <last_name>Aristeidis Chaidos</last_name>
      <role>Principal Investigator</role>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8D8</zip>
        <country>United Kingdom</country>
      </address>
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    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
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    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
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    <investigator>
      <last_name>Hannah Mary Hunter</last_name>
      <role>Principal Investigator</role>
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  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Belantamab Mafodotin</keyword>
  <keyword>Relapsed/Refractory Multiple Myeloma</keyword>
  <keyword>Pomalidomide</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>Bortezomib</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>Dexamethasone</mesh_term>
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </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/NCT04484623
org study id: 207499
secondary id: 2018-004354-21
nct id: NCT04484623
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with
      pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide,
      bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple
      myeloma (RRMM).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: Up to 84 months
description: PFS will be defined as the time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. The primary analysis of PFS will be based on Independent Review Committee (IRC) assessed response and dates per International Myeloma Working Group (IMWG) criteria.
measure: Duration of response (DoR)
time frame: Up to 84 months
description: DoR will be defined as the time from first documented evidence of partial response or better until progressive disease (PD) or death due to any cause.
measure: Minimal residual disease (MRD) negativity rate
time frame: Up to 84 months
description: MRD negativity rate will be defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing (NGS) at 10^5 threshold) at least once during the time of confirmed CR or better response, according to IMWG.
measure: Overall survival (OS)
time frame: Up to 84 months
description: OS will be defined as the time from randomization to death due to any cause.
measure: Overall response rate (ORR)
time frame: Up to 84 months
description: ORR will be defined as the percentage of participants with a confirmed partial response or better.
measure: Complete response rate (CRR)
time frame: Up to 84 months
description: CRR will be defined as the percentage of participants with a confirmed complete response or better.
measure: Very good partial response (VGPR) or better rate
time frame: Up to 84 months
description: VGPR will be the defined as the percentage of participants with a confirmed VGPR or better.
measure: Time to best response (TTBR)
time frame: Up to 84 months
description: TTBR will be defined as the time from the start of study treatment to the first documented evidence of best response among participants who achieve partial response or better.
measure: Time to response (TTR)
time frame: Up to 84 months
description: TTR will be defined as the time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.
measure: Time to progression (TTP)
time frame: Up to 84 months
description: TTP will be defined as the time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.
measure: Progression-free survival on subsequent line of therapy (PFS2)
time frame: Up to 84 months
description: PFS2 will be defined as the time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
time frame: Up to 84 months
measure: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
time frame: Up to 84 months
measure: Number of participants with abnormal ocular findings on ophthalmic examination
time frame: Up to 84 months
measure: Plasma concentrations of belantamab mafodotin at indicated time points
time frame: Up to 84 months
measure: Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
time frame: Up to 84 months
measure: Maximum observed concentration (Cmax) for pomalidomide
time frame: Up to 24 hours
measure: Time of Cmax (Tmax) for pomalidomide
time frame: Up to 24 hours
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for pomalidomide
time frame: Up to 24 hours
measure: Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
time frame: Up to 84 months
measure: Titers of ADAs against belantamab mafodotin
time frame: Up to 84 months
measure: Number of participants with maximum post-baseline changes in patient-reported outcome version of the common terminology criteria for adverse events (PRO-CTCAE) scores for each item attribute
time frame: Baseline and up to 84 months
description: PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.
measure: Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)
time frame: Baseline and up to 84 months
description: EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
measure: Change from Baseline in HRQoL as measured by EORTC item library 52 (IL52)
time frame: Baseline and up to 84 months
description: EORTC QLQ- 20-item Multiple Myeloma Module (MY20) questionnaire will be referred to as the EORTC IL52. Only disease symptoms domain will be assessed. A high score represents a high level of symptoms or problems.
measure: Change from Baseline in HRQoL as measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20)
time frame: Baseline and up to 84 months
description: EORTC QLQ-MY20 is a questionnaire which will evaluate disease symptoms. In EORTC QLQ-MY20, domain scores will be averaged and will be transformed linearly to a score ranging from 0 to 100. Higher score represents high level of symptomatology or problems.
arm group label: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
arm group type: Experimental
arm group label: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
arm group type: Experimental
intervention type: Drug
intervention name: Belantamab mafodotin
description: Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
arm group label: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
intervention type: Drug
intervention name: Pomalidomide
description: Immunomodulatory imide drug (IMiD) will be administered.
arm group label: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
arm group label: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Synthetic glucocorticoid with anti-tumor activity will be administered.
arm group label: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
arm group label: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
intervention type: Drug
intervention name: Bortezomib
description: Proteasome Inhibitor will be administered.
arm group label: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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
last name: EU GSK Clinical Trials Call Center
phone: +44 (0) 20 89904466
email: GSKClinicalSupportHD@gsk.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
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country: Australia
country: Brazil
country: Canada
country: China
country: Czechia
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: New Zealand
country: Poland
country: Russian Federation
country: Spain
country: Turkey
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Bortezomib
mesh term: Pomalidomide
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com