xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015542</url>
    </required_header>
    <id_info>
      <org_study_id>ERICA</org_study_id>
      <nct_id>NCT06015542</nct_id>
    </id_info>
    <brief_title>Self-administration of Subcutaneous Elranatamab in the Patients' Homes.</brief_title>
    <acronym>ERICA</acronym>
    <official_title>Self-administration of Subcutaneous Elranatamab in the Patients' Homes. An Open Label, Phase Two, Prospective, Non-randomized, Sponsor-initiated Explorative Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Odense University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Odense University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this open label, phase two, prospective, non-randomized, sponsor-initiated&#xD;
        explorative trial is to test self-administration of subcutaneous Elranatamab in the patients'&#xD;
        homes in patients with relapsed multiple myeloma exposed to at least one proteasome&#xD;
        inhibitor, one IMID and one anti CD-38 antibody. The main question[s]it aims to answer are:&#xD;
  &#xD;
          -  To evaluate the safety of self-administration of Elranatamab in the patients' own homes&#xD;
             using registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity&#xD;
             syndrome (ICANS) and infections.&#xD;
  &#xD;
          -  To evaluate the feasibility of self-administration of Elranatamab in the patients´ own&#xD;
             homes by registration of discarded doses, planned doses administered at home and doses&#xD;
             diverted from the patients' homes to the outpatient clinic.&#xD;
  &#xD;
          -  To elucidate the perspectives of patients and their caregivers of self-administration of&#xD;
             Elranatamab at home by interviewing both parties at end of treatment (EOT).&#xD;
  &#xD;
          -  To elucidate the perspectives of involved healthcare professionals in a focus group&#xD;
             interview at end of study (EOS).&#xD;
  &#xD;
          -  To clarify time spent on self-administration at home compared to administration at the&#xD;
             outpatient clinic by registering time consumption for patients, caregivers and&#xD;
             healthcare professionals.&#xD;
  &#xD;
          -  To evaluate the patients' QoL during self-administration using the European Organization&#xD;
             for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC&#xD;
             QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT&#xD;
             Cognitive).&#xD;
  &#xD;
          -  To clarify if self-administration in the patients' homes leads to additional unplanned&#xD;
             contacts with the healthcare system as a whole by weekly registration of any unplanned&#xD;
             contacts.&#xD;
  &#xD;
          -  To determine financial costs of self-administration at home compared to administration&#xD;
             at the outpatient clinic from the perspectives of patients, caregivers and the&#xD;
             healthcare system by collecting data on lost earnings, transport costs and salary costs.&#xD;
  &#xD;
          -  To evaluate the feasibility of the use of an electronic registration of side effects&#xD;
             prior to treatment by comparing electronic patient reported outcome (PRO) data to&#xD;
             registrations performed by nurses in the outpatient clinic during telephone&#xD;
             consultations.&#xD;
  &#xD;
        Participants will be asked to&#xD;
  &#xD;
          -  register time spend&#xD;
  &#xD;
          -  answer PRO-questionnaires&#xD;
  &#xD;
          -  weekly register any unplanned contact to the heathcare system&#xD;
  &#xD;
          -  be interviewed&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background Bispecific antibodies targeting CD3 and BCMA have demonstrated astonishing&#xD;
        efficacy with response rates of nearly 65 % in triple class exposed patients with multiple&#xD;
        myeloma (MM). This will not necessarily be the first product to be marketed, but might be a&#xD;
        product proven to be applicable for safe and convenient self-administration in the patients'&#xD;
        homes, thereby improving the patients' and their caregivers' Quality of Life (QoL) and&#xD;
        reducing the burden on the healthcare system. Although optimal dosing regimens are still&#xD;
        being investigated, most CD3xBCMA are given weekly until progression, with the possibility of&#xD;
        downscaling to twice monthly, if good remission is obtained. Consequently, patients have&#xD;
        multiple visits to the outpatient clinic, meaning that they spend a substantial amount of&#xD;
        time on transport, and that they are continuously exposed to potential infections.&#xD;
        Furthermore, the outpatient clinic might end out with many bispecific treatments in the&#xD;
        future, due to their high efficiency, thus straining the logistics of the hospital.&#xD;
  &#xD;
        Previous studies have shown that patients who administer their treatment themselves&#xD;
        experience better QoL, a higher level of well-being, and have a higher level of daily&#xD;
        activity. In addition, socio-economic savings of up to 20-50% are seen with&#xD;
        self-administration compared to outpatient treatment.&#xD;
  &#xD;
        Elranatamab is a bispecific CD3xBCMA with some unique properties; it is given subcutaneously&#xD;
        as a fixed dose, and it has shown a remarkably low risk of CRS after the third injection.&#xD;
        This makes it a perfect candidate to investigate in a setup, where patients are trained in&#xD;
        self-administration at their own homes.&#xD;
  &#xD;
        Acquiring source data and planned visits In the study, Elranatamab will be administered as&#xD;
        monotherapy for six cycles of 28 days (Table 1). Patients will receive subcutaneous&#xD;
        Elranatamab 76 mg QW with a 2-step-up priming dose regimen administered during the first week&#xD;
        (12 mg D1 and 32 mg D4). For safety reasons, the step-up doses will be administered with&#xD;
        hospitalization for a minimum of 48hr (C1D1) and 24hr (C1D4), respectively. During&#xD;
        hospitalization, vital signs will be measured at least 6 times per overnight stay. If&#xD;
        treatment is tolerated, C1D8, C1D15 and C1D22 will be administered in the outpatient clinic&#xD;
        and will include training of the patients in self-administration. In cycle 2 to cycle 6,&#xD;
        patients will administer the treatment themselves in the outpatient clinic D1 and at home D8,&#xD;
        D15 and D22. However, if patients experience any CRS during the study, the consecutive two&#xD;
        doses must be administered in the outpatient clinic without any signs of CRS, before home&#xD;
        treatment can be resumed. If patients experience ICANS, they will be taken off study.&#xD;
  &#xD;
        Prior to each new treatment cycle, laboratory assessments will be conducted at the local&#xD;
        hospital or at the patient's GP, according to general standards. A hematologist at Odense&#xD;
        University Hospital, who will also evaluate the patient, must accept the laboratory&#xD;
        assessments before D1 of all cycles.&#xD;
  &#xD;
        Further, the following data will be collected to meet the secondary endpoints:&#xD;
  &#xD;
        At inclusion, data on age, gender, marital status, PS, R-ISS, ISS, vital signs, myeloma type,&#xD;
        renal and liver function, concomitant medication (CM), weight, number of previous lines of&#xD;
        treatment and response to previous lines of treatment will be registered in an electronic&#xD;
        case report form (eCRF). Further, patients will be physically examined and cognitively&#xD;
        tested, which will include a writing test and a test of their ability to recognize known&#xD;
        pictures. Finally, patients must complete the EORTC QLQ-C30 and the FACT Cognitive&#xD;
        questionnaires electronically.&#xD;
  &#xD;
        During planned hospitalization in cycle 1, patients will be continuously examined, and data&#xD;
        on PS, vital signs, results of blood samples, CM, AEs and results of CRS and ICANS screening&#xD;
        will be collected. Similar data will be collected at C1D8, C1D15 and C1D22.&#xD;
  &#xD;
        Starting from cycle 2, data on location of administration will be collected. Specifically,&#xD;
        redirected administrations and discarded doses will be registered. When patients show in the&#xD;
        outpatient clinic at D1, they will be physically examined, and data on PS, vital signs,&#xD;
        results of blood samples, CM, AEs, weight and result of CRS and ICANS screening will be&#xD;
        collected. Further, patients should complete the EORTC QLQ-C30 electronically. If they do not&#xD;
        complete the questionnaire during their visit at the outpatient clinic, it can be completed&#xD;
        from home the following days, but no later than two days after treatment (D3).&#xD;
  &#xD;
        Before each home administration (D8, D15 and D22), patients will receive an electronic&#xD;
        questionnaire on their physical and cognitive condition. They must answer if they have had a&#xD;
        fever (they will be instructed in measuring their temperature before every injection),&#xD;
        dizziness or any other sickness, or if they have received any antibiotics since their last&#xD;
        administration. Further, to rule out any grade of ICANS, they will be cognitively tested. The&#xD;
        questionnaire must be filled in within two days prior to the administration. On the day of&#xD;
        treatment, a specialized nurse from the outpatient clinic will assess the responses and call&#xD;
        the patient in the morning to make sure there are no unexpected problems or fever, which&#xD;
        would be incompatible with treatment.&#xD;
  &#xD;
        At D1 (in the outpatient clinic) and D8 (at home) in cycle 2-6, patients, caregivers, nurses&#xD;
        and physicians in the outpatient clinic must register their time spent on the administration.&#xD;
        For patients and caregivers, this includes waiting time and time spent on transportation.&#xD;
        Further, they should register their mode of transportation and if they have had any need for&#xD;
        taking time off from work due to the planned administration. For nurses and physicians, this&#xD;
        includes both administrative and time spent with the patient.&#xD;
  &#xD;
        Throughout the study, patients must register if they have had any unplanned contact with the&#xD;
        healthcare system (e.g. to with the Department of Hematology or their GP). For this purpose,&#xD;
        they will automatically be contacted electronically each week, and if they register any&#xD;
        unplanned contacts, a study nurse will contact them for clarification and register the cause&#xD;
        of the contact.&#xD;
  &#xD;
        At EOT, patients and caregivers must complete a questionnaire on their preferences (treatment&#xD;
        at home or in the outpatient clinic). Moreover, patients must complete the EORTC QLQ-C30 and&#xD;
        FACT Cognitive questionnaires. Finally, patients and caregivers will be interviewed&#xD;
        individually.&#xD;
  &#xD;
        At EOS, a focus group interview with involved health care professionals at the outpatient&#xD;
        clinic will be conducted.&#xD;
  &#xD;
        Safety considerations and drug administration The most common AE associated with Elranatamab&#xD;
        is CRS. The treatments in the first cycle will be administered at the hospital; the two&#xD;
        priming doses with hospitalization and the others in the outpatient clinic. Further, to&#xD;
        reduce the grade of CRS, patients will receive premedications including corticosteroid,&#xD;
        antihistamine and antipyretic for both priming doses and for the first full dose. If no CRS&#xD;
        is observed, only antihistamine and antipyretic will be used in the following treatments.&#xD;
        Treatment will not be released for self-administration before cycle 2, at which time the risk&#xD;
        of severe CRS is considered minimal. Further, to reduce the risk of infections, patients will&#xD;
        receive infection prophylaxis in the form of Sulfametoxazole with Trimethoprim 80/400mg&#xD;
        daily, Ciprofloxacin 500mg twice daily, as well as immunoglobulin substitution, if polyclonal&#xD;
        IgG drops below 5 g/L.&#xD;
  &#xD;
        Before each new treatment cycle is initiated, laboratory assessments will be conducted at the&#xD;
        local hospital or the patient's GP, according to general standards. A hematologist at Odense&#xD;
        University Hospital, who will also evaluate the patient, must accept the laboratory&#xD;
        assessments before treatment is released. Before each home administration (D8, D15 and D22),&#xD;
        the patient must answer an electronic questionnaire on their physical and cognitive&#xD;
        condition. This includes questions on whether they have had a fever, dizziness or any other&#xD;
        sickness, and if they have received any antibiotics since last their last administration).&#xD;
        Further, to rule out any grade of CRS or infection, patients will be instructed in measuring&#xD;
        their temperature before every injection and report the result electronically. Finally, to&#xD;
        rule out any grade of ICANS, they will be cognitively tested, which will include a writing&#xD;
        test and a test of their ability to recognize known pictures.&#xD;
  &#xD;
        At the day of administration, a specialized nurse will assess the responses and call the&#xD;
        patient in the morning to make sure no unexpected problems or fever have occurred. If all&#xD;
        criteria are met, the nurse will contact the Hospital Pharmacy that will prepare the&#xD;
        treatment and send it directly to the patient by car.&#xD;
  &#xD;
        CRS and ICANS Management of CRS and ICANS will be handled as per local guideline following&#xD;
        ASTCT guidelines.&#xD;
  &#xD;
        If the patients experience CRS (any grade) at any time, the patients must receive the two&#xD;
        consecutive doses under observation at the hospital. Patients experiencing ICANS (any grade)&#xD;
        will be excluded from the study.&#xD;
  &#xD;
        Side effects Registration and reporting of AE, SAE and SUSAR All protocol registered AEs,&#xD;
        SAEs and product quality complaints, whether serious or non-serious, related or not related,&#xD;
        collected as per national guidelines to the licensed medical holder (©Pfizer) will be&#xD;
        registered in the eCRF. SAEs will be assessed by PI as either Suspected Adverse Reaction&#xD;
        (SAR), Suspected Unexpected Serious Adverse Reactions (SUSAR) or non-related SAE. SARs and&#xD;
        SUSARs will be reported to the medical license holder within 24 hours of investigator&#xD;
        acknowledgement using the Investigator Sponsored Research or Clinical Research Collaboration&#xD;
        Interventional Study Serious Adverse Event Form V. 5.0. The form can be completed by a study&#xD;
        coordinator, but should be signed by PI (MD. PhD, Thomas Lund) as soon as possible. However,&#xD;
        the signature should not delay submission of the form beyond the 24 hours.&#xD;
  &#xD;
        Non-related SAEs and AEs will be reported every third month to Pfizer and annually to the&#xD;
        Danish Medical Agency.&#xD;
  &#xD;
        Side effects Registration and reporting of AE, SAE and SUSAR All protocol registered AEs,&#xD;
        SAEs and product quality complaints, whether serious or non-serious, related or not related,&#xD;
        collected as per national guidelines to the licensed medical holder (©Pfizer) will be&#xD;
        registered in the eCRF. SAEs will be assessed by PI as either Suspected Adverse Reaction&#xD;
        (SAR), Suspected Unexpected Serious Adverse Reactions (SUSAR) or non-related SAE. SARs and&#xD;
        SUSARs will be reported to the medical license holder within 24 hours of investigator&#xD;
        acknowledgement using the Investigator Sponsored Research or Clinical Research Collaboration&#xD;
        Interventional Study Serious Adverse Event Form V. 5.0. The form can be completed by a study&#xD;
        coordinator, but should be signed by PI (MD. PhD, Thomas Lund) as soon as possible. However,&#xD;
        the signature should not delay submission of the form beyond the 24 hours. The SAE form&#xD;
        should be sent to the following password-protected e-mail: DNK.AEReporting@pfizer.com&#xD;
        Non-related SAEs and AEs will be reported every third month to Pfizer and annually to the&#xD;
        Danish Medical Agency.&#xD;
  &#xD;
        The NCI CTCAE v 4.0 is used for grading the severity of AEs. Each dose modification or&#xD;
        treatment delay, as well as the reason will be documented in the eCRF. AEs and SAEs will be&#xD;
        registered from first dose of treatment until 28 calendar days after the last dose of&#xD;
        Elranatamab in the study. In addition, any AE/SAE occurring after the 28-day period will also&#xD;
        be registered, if PI suspects a causal relationship between Elranatamab and the AE/SAE. Signs&#xD;
        or symptoms directly related to MM or planned hospitalization for earlier known diseases will&#xD;
        not be registered.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>An open label, phase two, prospective, non-randomized, sponsor-initiated explorative trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>Registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>registration of discarded doses, planned doses administered at home and doses diverted from the patients' homes to the outpatient clinic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home</measure>
      <time_frame>approximately 1 hour</time_frame>
      <description>interviewing both parties at end of treatment (EOT).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>elucidate the perspectives of involved healthcare professionals</measure>
      <time_frame>approximately 2 hours</time_frame>
      <description>performing a focus group interview at end of study (EOS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clarify time spent on self-administration at home compared to administration at the outpatient clinic</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>registering time consumption for patients, caregivers and healthcare professionals.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluate the patients' QoL during self-administration</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT Cognitive).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clarify if self-administration in the patients' homes leads to additional unplanned contacts with the healthcare system as a whole</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>weekly registration of any unplanned contacts.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>determine financial costs of self-administration at home compared to administration at the outpatient clinic from the perspectives of patients, caregivers and the healthcare system</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>collecting data on lost earnings, transport costs and salary costs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluate the feasibility of the use of an electronic registration of side effects prior to treatment</measure>
      <time_frame>approximately 24 weeks</time_frame>
      <description>comparing electronic patient reported outcome (PRO) data to registrations performed by nurses in the outpatient clinic during telephone consultations.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Self-administration of Elranatamab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It is a feasibility study assessing the feasibility and safety of self-administration of Elranatamab in the homes of the patients. The intervention of the study is self-administration of Elranatamab by the patient, thereby changing the administration from an outpatient setting to a home setting. The patients will function as their own controls, as treatment will be given alternately at home and in the outpatient clinic.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Elranatamab</intervention_name>
      <description>Elranatamab will be administered as monotherapy for six cycles of 28 days. Elranatamab 76 mg will be administered QW with a 2-step-up priming dose regimen administered during the first week (12 mg D1 and 32 mg D4).</description>
      <arm_group_label>Self-administration of Elranatamab</arm_group_label>
      <other_name>PF-06863135</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  ≥ 18 years of age at the time of signing the informed consent form.&#xD;
  &#xD;
            -  Relapsed MM according to the IMWG criteria.&#xD;
  &#xD;
            -  Measurable disease defined as: M-protein quantities ≥ 0.5 g/dL by serum protein&#xD;
               electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein&#xD;
               electrophoresis (uPEP) and/or Serum free light chain (FLC) levels &gt; 100 mg/L (10&#xD;
               mg/dL) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in patients&#xD;
               without measurable disease in the serum or urine.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2.&#xD;
  &#xD;
            -  Previously exposed to at least one proteasome inhibitor, one IMID and one anti CD-38&#xD;
               antibody.&#xD;
  &#xD;
            -  Documented disease progression during or after last anti-myeloma regimen.&#xD;
  &#xD;
            -  Possibility of being observed by a capable caregiver during self-administration.&#xD;
  &#xD;
            -  ANC ≥1.0 x 109/L (G-CSF allowed).&#xD;
  &#xD;
            -  Platelets ≥25 x 109/L.&#xD;
  &#xD;
            -  Female patients of childbearing potential must have a negative serum pregnancy test at&#xD;
               screening. Female patients of childbearing potential and fertile male patients who are&#xD;
               sexually active with a female of childbearing potential must use highly effective&#xD;
               methods of contraception throughout the study and for 3 months following the last dose&#xD;
               of study treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any significant medical condition, laboratory abnormality or psychiatric illness that&#xD;
               would prevent the subject from participating in the study.&#xD;
  &#xD;
            -  Prior history of ICANS.&#xD;
  &#xD;
            -  Prior history of malignancies, other than MM, unless the subject has been free of the&#xD;
               disease for ≥ 5 years with the exception of the following non-invasive malignancies:&#xD;
  &#xD;
                 -  Basal cell carcinoma of the skin&#xD;
  &#xD;
                 -  Squamous cell carcinoma of the skin&#xD;
  &#xD;
                 -  Carcinoma in situ of the cervix&#xD;
  &#xD;
                 -  Carcinoma in situ of the breast&#xD;
  &#xD;
                 -  Incidental histologic finding of prostate cancer (T1a or T1b using the TNM&#xD;
                    [tumor, nodes and metastasis] clinical staging system) or prostate cancer that is&#xD;
                    curative&#xD;
  &#xD;
            -  Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy,&#xD;
               organomegaly, endocrinopathy, monoclonal protein and skin changes) or clinically&#xD;
               significant Amyloidosis.&#xD;
  &#xD;
            -  Female who is pregnant, breastfeeding or who intends to become pregnant during the&#xD;
               participation in the study.&#xD;
  &#xD;
            -  Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B or&#xD;
               active hepatitis A or C.&#xD;
  &#xD;
            -  Resident on an unbridged island.&#xD;
  &#xD;
            -  Not being able to register PRO-data electronically.&#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>Thomas Lund, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Odense Universitetshospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jannie Kirkegaard, RN</last_name>
      <phone>+45 29648494</phone>
      <email>Jannie.kirkegaard@rsyd.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tine Rosenberg, MSc</last_name>
      <phone>+45 21370942</phone>
      <email>tine.rosenberg@rsyd.dk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The study population is a relatively small patient group. Rewieling of IPD will potentially be a risk to human rights.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015542
  org study id: ERICA
  nct id: NCT06015542
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this open label, phase two, prospective, non-randomized, sponsor-initiated
        explorative trial is to test self-administration of subcutaneous Elranatamab in the patients'
        homes in patients with relapsed multiple myeloma exposed to at least one proteasome
        inhibitor, one IMID and one anti CD-38 antibody. The main question[s]it aims to answer are:
  
          -  To evaluate the safety of self-administration of Elranatamab in the patients' own homes
             using registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity
             syndrome (ICANS) and infections.
  
          -  To evaluate the feasibility of self-administration of Elranatamab in the patients´ own
             homes by registration of discarded doses, planned doses administered at home and doses
             diverted from the patients' homes to the outpatient clinic.
  
          -  To elucidate the perspectives of patients and their caregivers of self-administration of
             Elranatamab at home by interviewing both parties at end of treatment (EOT).
  
          -  To elucidate the perspectives of involved healthcare professionals in a focus group
             interview at end of study (EOS).
  
          -  To clarify time spent on self-administration at home compared to administration at the
             outpatient clinic by registering time consumption for patients, caregivers and
             healthcare professionals.
  
          -  To evaluate the patients' QoL during self-administration using the European Organization
             for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC
             QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT
             Cognitive).
  
          -  To clarify if self-administration in the patients' homes leads to additional unplanned
             contacts with the healthcare system as a whole by weekly registration of any unplanned
             contacts.
  
          -  To determine financial costs of self-administration at home compared to administration
             at the outpatient clinic from the perspectives of patients, caregivers and the
             healthcare system by collecting data on lost earnings, transport costs and salary costs.
  
          -  To evaluate the feasibility of the use of an electronic registration of side effects
             prior to treatment by comparing electronic patient reported outcome (PRO) data to
             registrations performed by nurses in the outpatient clinic during telephone
             consultations.
  
        Participants will be asked to
  
          -  register time spend
  
          -  answer PRO-questionnaires
  
          -  weekly register any unplanned contact to the heathcare system
  
          -  be interviewed
  Background Bispecific antibodies targeting CD3 and BCMA have demonstrated astonishing
        efficacy with response rates of nearly 65 % in triple class exposed patients with multiple
        myeloma (MM). This will not necessarily be the first product to be marketed, but might be a
        product proven to be applicable for safe and convenient self-administration in the patients'
        homes, thereby improving the patients' and their caregivers' Quality of Life (QoL) and
        reducing the burden on the healthcare system. Although optimal dosing regimens are still
        being investigated, most CD3xBCMA are given weekly until progression, with the possibility of
        downscaling to twice monthly, if good remission is obtained. Consequently, patients have
        multiple visits to the outpatient clinic, meaning that they spend a substantial amount of
        time on transport, and that they are continuously exposed to potential infections.
        Furthermore, the outpatient clinic might end out with many bispecific treatments in the
        future, due to their high efficiency, thus straining the logistics of the hospital.
  
        Previous studies have shown that patients who administer their treatment themselves
        experience better QoL, a higher level of well-being, and have a higher level of daily
        activity. In addition, socio-economic savings of up to 20-50% are seen with
        self-administration compared to outpatient treatment.
  
        Elranatamab is a bispecific CD3xBCMA with some unique properties; it is given subcutaneously
        as a fixed dose, and it has shown a remarkably low risk of CRS after the third injection.
        This makes it a perfect candidate to investigate in a setup, where patients are trained in
        self-administration at their own homes.
  
        Acquiring source data and planned visits In the study, Elranatamab will be administered as
        monotherapy for six cycles of 28 days (Table 1). Patients will receive subcutaneous
        Elranatamab 76 mg QW with a 2-step-up priming dose regimen administered during the first week
        (12 mg D1 and 32 mg D4). For safety reasons, the step-up doses will be administered with
        hospitalization for a minimum of 48hr (C1D1) and 24hr (C1D4), respectively. During
        hospitalization, vital signs will be measured at least 6 times per overnight stay. If
        treatment is tolerated, C1D8, C1D15 and C1D22 will be administered in the outpatient clinic
        and will include training of the patients in self-administration. In cycle 2 to cycle 6,
        patients will administer the treatment themselves in the outpatient clinic D1 and at home D8,
        D15 and D22. However, if patients experience any CRS during the study, the consecutive two
        doses must be administered in the outpatient clinic without any signs of CRS, before home
        treatment can be resumed. If patients experience ICANS, they will be taken off study.
  
        Prior to each new treatment cycle, laboratory assessments will be conducted at the local
        hospital or at the patient's GP, according to general standards. A hematologist at Odense
        University Hospital, who will also evaluate the patient, must accept the laboratory
        assessments before D1 of all cycles.
  
        Further, the following data will be collected to meet the secondary endpoints:
  
        At inclusion, data on age, gender, marital status, PS, R-ISS, ISS, vital signs, myeloma type,
        renal and liver function, concomitant medication (CM), weight, number of previous lines of
        treatment and response to previous lines of treatment will be registered in an electronic
        case report form (eCRF). Further, patients will be physically examined and cognitively
        tested, which will include a writing test and a test of their ability to recognize known
        pictures. Finally, patients must complete the EORTC QLQ-C30 and the FACT Cognitive
        questionnaires electronically.
  
        During planned hospitalization in cycle 1, patients will be continuously examined, and data
        on PS, vital signs, results of blood samples, CM, AEs and results of CRS and ICANS screening
        will be collected. Similar data will be collected at C1D8, C1D15 and C1D22.
  
        Starting from cycle 2, data on location of administration will be collected. Specifically,
        redirected administrations and discarded doses will be registered. When patients show in the
        outpatient clinic at D1, they will be physically examined, and data on PS, vital signs,
        results of blood samples, CM, AEs, weight and result of CRS and ICANS screening will be
        collected. Further, patients should complete the EORTC QLQ-C30 electronically. If they do not
        complete the questionnaire during their visit at the outpatient clinic, it can be completed
        from home the following days, but no later than two days after treatment (D3).
  
        Before each home administration (D8, D15 and D22), patients will receive an electronic
        questionnaire on their physical and cognitive condition. They must answer if they have had a
        fever (they will be instructed in measuring their temperature before every injection),
        dizziness or any other sickness, or if they have received any antibiotics since their last
        administration. Further, to rule out any grade of ICANS, they will be cognitively tested. The
        questionnaire must be filled in within two days prior to the administration. On the day of
        treatment, a specialized nurse from the outpatient clinic will assess the responses and call
        the patient in the morning to make sure there are no unexpected problems or fever, which
        would be incompatible with treatment.
  
        At D1 (in the outpatient clinic) and D8 (at home) in cycle 2-6, patients, caregivers, nurses
        and physicians in the outpatient clinic must register their time spent on the administration.
        For patients and caregivers, this includes waiting time and time spent on transportation.
        Further, they should register their mode of transportation and if they have had any need for
        taking time off from work due to the planned administration. For nurses and physicians, this
        includes both administrative and time spent with the patient.
  
        Throughout the study, patients must register if they have had any unplanned contact with the
        healthcare system (e.g. to with the Department of Hematology or their GP). For this purpose,
        they will automatically be contacted electronically each week, and if they register any
        unplanned contacts, a study nurse will contact them for clarification and register the cause
        of the contact.
  
        At EOT, patients and caregivers must complete a questionnaire on their preferences (treatment
        at home or in the outpatient clinic). Moreover, patients must complete the EORTC QLQ-C30 and
        FACT Cognitive questionnaires. Finally, patients and caregivers will be interviewed
        individually.
  
        At EOS, a focus group interview with involved health care professionals at the outpatient
        clinic will be conducted.
  
        Safety considerations and drug administration The most common AE associated with Elranatamab
        is CRS. The treatments in the first cycle will be administered at the hospital; the two
        priming doses with hospitalization and the others in the outpatient clinic. Further, to
        reduce the grade of CRS, patients will receive premedications including corticosteroid,
        antihistamine and antipyretic for both priming doses and for the first full dose. If no CRS
        is observed, only antihistamine and antipyretic will be used in the following treatments.
        Treatment will not be released for self-administration before cycle 2, at which time the risk
        of severe CRS is considered minimal. Further, to reduce the risk of infections, patients will
        receive infection prophylaxis in the form of Sulfametoxazole with Trimethoprim 80/400mg
        daily, Ciprofloxacin 500mg twice daily, as well as immunoglobulin substitution, if polyclonal
        IgG drops below 5 g/L.
  
        Before each new treatment cycle is initiated, laboratory assessments will be conducted at the
        local hospital or the patient's GP, according to general standards. A hematologist at Odense
        University Hospital, who will also evaluate the patient, must accept the laboratory
        assessments before treatment is released. Before each home administration (D8, D15 and D22),
        the patient must answer an electronic questionnaire on their physical and cognitive
        condition. This includes questions on whether they have had a fever, dizziness or any other
        sickness, and if they have received any antibiotics since last their last administration).
        Further, to rule out any grade of CRS or infection, patients will be instructed in measuring
        their temperature before every injection and report the result electronically. Finally, to
        rule out any grade of ICANS, they will be cognitively tested, which will include a writing
        test and a test of their ability to recognize known pictures.
  
        At the day of administration, a specialized nurse will assess the responses and call the
        patient in the morning to make sure no unexpected problems or fever have occurred. If all
        criteria are met, the nurse will contact the Hospital Pharmacy that will prepare the
        treatment and send it directly to the patient by car.
  
        CRS and ICANS Management of CRS and ICANS will be handled as per local guideline following
        ASTCT guidelines.
  
        If the patients experience CRS (any grade) at any time, the patients must receive the two
        consecutive doses under observation at the hospital. Patients experiencing ICANS (any grade)
        will be excluded from the study.
  
        Side effects Registration and reporting of AE, SAE and SUSAR All protocol registered AEs,
        SAEs and product quality complaints, whether serious or non-serious, related or not related,
        collected as per national guidelines to the licensed medical holder (©Pfizer) will be
        registered in the eCRF. SAEs will be assessed by PI as either Suspected Adverse Reaction
        (SAR), Suspected Unexpected Serious Adverse Reactions (SUSAR) or non-related SAE. SARs and
        SUSARs will be reported to the medical license holder within 24 hours of investigator
        acknowledgement using the Investigator Sponsored Research or Clinical Research Collaboration
        Interventional Study Serious Adverse Event Form V. 5.0. The form can be completed by a study
        coordinator, but should be signed by PI (MD. PhD, Thomas Lund) as soon as possible. However,
        the signature should not delay submission of the form beyond the 24 hours.
  
        Non-related SAEs and AEs will be reported every third month to Pfizer and annually to the
        Danish Medical Agency.
  
        Side effects Registration and reporting of AE, SAE and SUSAR All protocol registered AEs,
        SAEs and product quality complaints, whether serious or non-serious, related or not related,
        collected as per national guidelines to the licensed medical holder (©Pfizer) will be
        registered in the eCRF. SAEs will be assessed by PI as either Suspected Adverse Reaction
        (SAR), Suspected Unexpected Serious Adverse Reactions (SUSAR) or non-related SAE. SARs and
        SUSARs will be reported to the medical license holder within 24 hours of investigator
        acknowledgement using the Investigator Sponsored Research or Clinical Research Collaboration
        Interventional Study Serious Adverse Event Form V. 5.0. The form can be completed by a study
        coordinator, but should be signed by PI (MD. PhD, Thomas Lund) as soon as possible. However,
        the signature should not delay submission of the form beyond the 24 hours. The SAE form
        should be sent to the following password-protected e-mail: DNK.AEReporting@pfizer.com
        Non-related SAEs and AEs will be reported every third month to Pfizer and annually to the
        Danish Medical Agency.
  
        The NCI CTCAE v 4.0 is used for grading the severity of AEs. Each dose modification or
        treatment delay, as well as the reason will be documented in the eCRF. AEs and SAEs will be
        registered from first dose of treatment until 28 calendar days after the last dose of
        Elranatamab in the study. In addition, any AE/SAE occurring after the 28-day period will also
        be registered, if PI suspects a causal relationship between Elranatamab and the AE/SAE. Signs
        or symptoms directly related to MM or planned hospitalization for earlier known diseases will
        not be registered.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: An open label, phase two, prospective, non-randomized, sponsor-initiated explorative trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist
  time frame: approximately 24 weeks
  description: Registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.
  measure: evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes
  time frame: approximately 24 weeks
  description: registration of discarded doses, planned doses administered at home and doses diverted from the patients' homes to the outpatient clinic.
  measure: elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home
  time frame: approximately 1 hour
  description: interviewing both parties at end of treatment (EOT).
  measure: elucidate the perspectives of involved healthcare professionals
  time frame: approximately 2 hours
  description: performing a focus group interview at end of study (EOS).
  measure: clarify time spent on self-administration at home compared to administration at the outpatient clinic
  time frame: approximately 24 weeks
  description: registering time consumption for patients, caregivers and healthcare professionals.
  measure: evaluate the patients' QoL during self-administration
  time frame: approximately 24 weeks
  description: using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT Cognitive).
  measure: clarify if self-administration in the patients' homes leads to additional unplanned contacts with the healthcare system as a whole
  time frame: approximately 24 weeks
  description: weekly registration of any unplanned contacts.
  measure: determine financial costs of self-administration at home compared to administration at the outpatient clinic from the perspectives of patients, caregivers and the healthcare system
  time frame: approximately 24 weeks
  description: collecting data on lost earnings, transport costs and salary costs
  measure: evaluate the feasibility of the use of an electronic registration of side effects prior to treatment
  time frame: approximately 24 weeks
  description: comparing electronic patient reported outcome (PRO) data to registrations performed by nurses in the outpatient clinic during telephone consultations.
  arm group label: Self-administration of Elranatamab
  arm group type: Experimental
  description: It is a feasibility study assessing the feasibility and safety of self-administration of Elranatamab in the homes of the patients. The intervention of the study is self-administration of Elranatamab by the patient, thereby changing the administration from an outpatient setting to a home setting. The patients will function as their own controls, as treatment will be given alternately at home and in the outpatient clinic.
  intervention type: Drug
  intervention name: Elranatamab
  description: Elranatamab will be administered as monotherapy for six cycles of 28 days. Elranatamab 76 mg will be administered QW with a 2-step-up priming dose regimen administered during the first week (12 mg D1 and 32 mg D4).
  arm group label: Self-administration of Elranatamab
  other name: PF-06863135
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas Lund, MD
  role: Principal Investigator
  affiliation: Odense Universitetshospital
  last name: Jannie Kirkegaard, RN
  phone: +45 29648494
  email: Jannie.kirkegaard@rsyd.dk
  last name: Tine Rosenberg, MSc
  phone: +45 21370942
  email: tine.rosenberg@rsyd.dk
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  sharing ipd: No
  ipd description: The study population is a relatively small patient group. Rewieling of IPD will potentially be a risk to human rights.