<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/NCT03836053</url>
  </required_header>
  <id_info>
    <org_study_id>20160370</org_study_id>
    <nct_id>NCT03836053</nct_id>
  </id_info>
  <brief_title>Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma</brief_title>
  <acronym>AMG420</acronym>
  <official_title>A Phase 1b Multicenter, Open-label, Expansion Study to Assess the Safety and Efficacy of AMG 420 as Monotherapy in Subjects With Relapsed and/or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</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>
      To confirm the maximum tolerated dose (MTD) from the BI 836909 trial of 400 mcg/d, given as&#xD;
      28-day continuous intravenous infusion in patients with relapsed and/or refractory multiple&#xD;
      myeloma, to test the 600 mcg/d dose, given as a 28-day continuous iV infusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cohort 1 will consist of 10 subjects dosed at 400 mcg/d. Cohort 2 will consist of 10 subjects&#xD;
      dosed at 600 mcg/d. All doses will be given as a 28-day continuous IV infusion, followed by a&#xD;
      2 week treatment-free interval, until subject experiences disease progression as per&#xD;
      International Myeloma Working Group (IMWG) criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">April 21, 2022</completion_date>
  <primary_completion_date type="Actual">April 21, 2022</primary_completion_date>
  <phase>Phase 1</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>Phase 1b Primary objective Establish the safety and tolerability of AMG 420 at dose levels of 400 mcg/day and 600 mcg/day in subjects with relapsed and/or refractory multiple myeloma (RRMM)&#xD;
Phase 1b Key Secondary/Secondary objectives:&#xD;
Estimate overall response rate (ORR) and duration of response (DOR) Evaluate the rate of minimal residual disease (MRD)-negativity at the time of CR Establish the safety and tolerability of AMG 420 in subjects with extramedullary relapsed MM Characterize the PK of AMG 420 when administered as 4-week continuous IV infusion Evaluate other measures of anti-myeloma activity of AMG 420: Time to response, PFS, OS, TFI, BOR</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject incidence of dose-limiting toxicities</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate incidence of subjects experiencing dose-limiting toxicities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject incidence of treatment emergent adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate incidence of subjects experiencing treatment emergent adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject incidence of treatment related adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate incidence of subjects experiencing treatment related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject incidence of changes in vital signs</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate incidence of subjects experiencing changes in vital signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject Incidence of Changes in ECGs</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate incidence of subjects experiencing changes in ECGs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject incidence of Changes in clinical laboratory tests</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate incidence of subjects experiencing changes in clinical laboratory tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the rate of subjects responding to treatment with AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the duration of subject responses to treatment with AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal Residual Disease negativity at the time of CR</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate MRD negativity at the time a subject achieves complete response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life</measure>
    <time_frame>4 weeks</time_frame>
    <description>Half life of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>6 months</time_frame>
    <description>Time to response of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance</measure>
    <time_frame>6 months</time_frame>
    <description>Clearance of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Css</measure>
    <time_frame>6 months</time_frame>
    <description>Apparent Css of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>6 months</time_frame>
    <description>PFS of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>6 months</time_frame>
    <description>OS of of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response</measure>
    <time_frame>6 months</time_frame>
    <description>BOR of AMG 420</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-free Interval</measure>
    <time_frame>6 months</time_frame>
    <description>TFI of AMG 420</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Relapsed and/or Refractory Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>AMG 420</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Arm Design</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 420</intervention_name>
    <description>28 day continuous Intravenous infusion of either 400 mcg/d or 600 mcg/d followed by 2 treatment free weeks</description>
    <arm_group_label>AMG 420</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Subject has provided informed consent prior to initiation of any study specific&#xD;
             activities/procedures&#xD;
&#xD;
          2. Multiple myeloma meeting the following criteria:&#xD;
&#xD;
          3. Pathologically-documented diagnosis of multiple myeloma that is relapsed or is&#xD;
             refractory as defined by the following: Relapsed after 3 or more lines of prior&#xD;
             therapy that must include a proteasome inhibitors (PI), an immunomodulators (IMiD),&#xD;
             and a CD38-directed monoclonal antibody in any order during the course of treatment OR&#xD;
             refractory to a PI, IMiD, and CD38-directed monoclonal antibody.&#xD;
&#xD;
             -Measurable disease, defined by 1 or more of the following at time of screening: 1)&#xD;
             serum M-protein &gt; 0.5 g/dL measured by serum protein electrophoresis (SPEP); 2)&#xD;
             urinary M-protein excretion &gt; 200 mg/24 hours; 3) Involved serum free light chain&#xD;
             (sFLC ) measurement &gt; 10 mg/dL, provided that the sFLC ratio is abnormal (&lt;0.26 or&#xD;
             &gt;1.65) as per IMWG response criteria&#xD;
&#xD;
          4. . ECOG performance status of less than or equal to 2&#xD;
&#xD;
          5. Life expectancy of at least 3 months per PI judgement at screening&#xD;
&#xD;
          6. Hematological function without transfusion support (within 7 days from screening&#xD;
             assessment) as follows:&#xD;
&#xD;
               -  ANC ≥ 1.0 x 10^9/L (without growth factor support)&#xD;
&#xD;
               -  platelet count ≥ 25 x 10^9/L (without transfusions)&#xD;
&#xD;
               -  hemoglobin ≥ 7.0 g/dL (transfusions permitted no later than 48 hours before&#xD;
                  screening)&#xD;
&#xD;
          7. Renal function as follows: calculated or measured creatinine clearance ≥30 mL/min&#xD;
             using the Cockcroft-Gault equation or via 24-hour urine collection with plasma and&#xD;
             urine creatinine concentrations, respectively&#xD;
&#xD;
          8. Hepatic function as follows: AST and ALT &lt; 3x upper limit of normal (ULN); TBIL &lt;1.5 x&#xD;
             ULN (unless considered due to Gilbert's syndrome)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Known central nervous system involvement by multiple myeloma&#xD;
&#xD;
          2. Evidence of primary or secondary plasma cell leukemia at the time of screening&#xD;
&#xD;
          3. Waldenstrom's macroglobulinemia&#xD;
&#xD;
          4. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to&#xD;
             CTCAE version 5.0 grade 1 or to levels dictated in the eligibility criteria with the&#xD;
             exception of grade 2 peripheral neuropathy, alopecia, or toxicities from prior&#xD;
             anticancer therapy that are considered irreversible (defined as having been present&#xD;
             and stable for &gt; 4 weeks) which may be allowed if they are not otherwise described in&#xD;
             the exclusion criteria and there is agreement to allow by the PI and Amgen medical&#xD;
             monitor&#xD;
&#xD;
          5. History of other malignancy within the past 3 years, with the following exceptions: 1.&#xD;
             malignancy treated with curative intent and with no known active disease present for ≥&#xD;
             1 year before enrollment and felt to be at low risk for recurrence by the treating&#xD;
             physician; 2. adequately-treated non-melanoma skin cancer or lentigo maligna without&#xD;
             evidence of disease; 3. adequately-treated cervical carcinoma in situ without evidence&#xD;
             of disease; 4. breast ductal carcinoma in situ with full surgical resection (ie,&#xD;
             negative margins) and without evidence of disease; 5. prostate cancer with a Gleason&#xD;
             score &lt; 6 with undetectable PSA over 12 months; 6. treated medullary or papillary&#xD;
             thyroid cancer; 7. adequately-treated urothelial papillary noninvasive carcinoma or&#xD;
             carcinoma in situ; similar neoplastic conditions with an expectation of &gt; 95%&#xD;
             five-year disease-free survival; 8. see exclusion criterion # 2 for exclusion of&#xD;
             subjects with evidence of primary or secondary plasma cell leukemia at the time of&#xD;
             screening&#xD;
&#xD;
          6. Known history of amyloidosis&#xD;
&#xD;
          7. Current or known history of autoimmune diseases requiring systemic treatment in past 5&#xD;
             years except vitiligo, resolved childhood asthma/atopy, or subjects with history of&#xD;
             hypothyroidism after completing treatment for autoimmune thyroid disease, stable on&#xD;
             hormone replacement therapy.&#xD;
&#xD;
          8. Clinically not-controlled chronic or ongoing infectious disease requiring treatment at&#xD;
             the time of study day 1 or within the 14 days before study day 1&#xD;
&#xD;
          9. Symptomatic peripheral sensory or motor neuropathy of grade ≥3&#xD;
&#xD;
         10. History or presence of clinically relevant central nervous system (CNS) pathology as&#xD;
             uncontrolled epilepsy or seizure disorder, paresis, aphasia, stroke, severe brain&#xD;
             injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome,&#xD;
             and psychosis&#xD;
&#xD;
         11. Active hepatitis B and C based on the following results: a) Positive for HepBsAg; b)&#xD;
             Negative HepBsAg and positive for hepatitis B core antibody; c) Positive Hepatitis C&#xD;
             virus antibody (HepCAb)&#xD;
&#xD;
         12. Known or suspected HIV infection or subjects who are HIV seropositive&#xD;
&#xD;
         13. Baseline ECG QTc &gt; 470 msec (applying Fridericia correction)&#xD;
&#xD;
         14. Previously received an allogeneic stem cell transplant and the occurrence of 1 or more&#xD;
             of the following: a) received the transplant within 6 months prior to study day 1; b)&#xD;
             received immunosuppressive therapy within the last 3 months prior to study day 1; c)&#xD;
             any active acute graft versus host disease (GvHD), grade 2 to 4, according to the&#xD;
             Glucksberg criteria or active chronic GvHD requiring systemic treatment; d) any&#xD;
             systemic therapy against GvHD within 2 weeks prior to start of investigational product&#xD;
             treatment&#xD;
&#xD;
         15. Autologous stem cell transplantation &lt; 90 days prior to study day 1&#xD;
&#xD;
         16. Treatment with systemic immune modulators including, but not limited to, nontopical&#xD;
             systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent),&#xD;
             cyclosporine, and tacrolimus within 2 weeks before study day 1&#xD;
&#xD;
         17. Last anticancer treatment &lt; 2 weeks prior to study day 1&#xD;
&#xD;
         18. Last treatment with a therapeutic antibody less than 4 weeks prior to study day 1&#xD;
&#xD;
         19. Systemic radiation therapy within 28 days prior to study day 1. Focal radiotherapy&#xD;
             within 14 days prior to study day 1.&#xD;
&#xD;
         20. Major surgery defined as surgery requiring general anesthesia with endotracheal&#xD;
             intubation within 28 days prior to study day 1, unless discussed with and eligibility&#xD;
             approved by Amgen medical monitor&#xD;
&#xD;
         21. Prior treatment with any drug that specifically targets BCMA on tumor cells (eg, other&#xD;
             bi-specific antibody constructs, antibody drug conjugates, or CAR T-cells, except for&#xD;
             subjects who were previously treated with AMG 420 in this study and who are candidates&#xD;
             for second-course treatment&#xD;
&#xD;
         22. Treatment with medications known to cause QTc interval prolongation within the washout&#xD;
             periods described in Section 12.10 unless approved by the Amgen medical monitor&#xD;
&#xD;
         23. Currently receiving treatment in another investigational device or drug study, or less&#xD;
             than 30 days since ending treatment on another investigational device or drug&#xD;
             study(ies). Other investigational procedures while participating in this study are&#xD;
             excluded.&#xD;
&#xD;
         24. History or evidence of any other clinically-significant disorder, condition, or&#xD;
             disease (eg, symptomatic congestive heart failure, unstable angina pectoris,cardiac&#xD;
             arrhythmia requiring therapy at time of screening) with the exception of those&#xD;
             outlined above that, in the opinion of the investigator or Amgen medical monitor, if&#xD;
             consulted, would pose a risk to subject safety or interfere with the study evaluation,&#xD;
             procedures, or completion.&#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>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Melbourne</name>
      <address>
        <city>Fitzroy, VIC</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centres Hospitaliers Jolimont - Hopital de Jolimont</name>
      <address>
        <city>Haine Saint Paul - La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Okayama Medical Center</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St Gallen</name>
      <address>
        <city>St. Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Japan</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</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>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</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>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>March 28, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03836053
org study id: 20160370
nct id: NCT03836053
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To confirm the maximum tolerated dose (MTD) from the BI 836909 trial of 400 mcg/d, given as
      28-day continuous intravenous infusion in patients with relapsed and/or refractory multiple
      myeloma, to test the 600 mcg/d dose, given as a 28-day continuous iV infusion.
Cohort 1 will consist of 10 subjects dosed at 400 mcg/d. Cohort 2 will consist of 10 subjects
      dosed at 600 mcg/d. All doses will be given as a 28-day continuous IV infusion, followed by a
      2 week treatment-free interval, until subject experiences disease progression as per
      International Myeloma Working Group (IMWG) criteria.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Phase 1b Primary objective Establish the safety and tolerability of AMG 420 at dose levels of 400 mcg/day and 600 mcg/day in subjects with relapsed and/or refractory multiple myeloma (RRMM)
Phase 1b Key Secondary/Secondary objectives:
Estimate overall response rate (ORR) and duration of response (DOR) Evaluate the rate of minimal residual disease (MRD)-negativity at the time of CR Establish the safety and tolerability of AMG 420 in subjects with extramedullary relapsed MM Characterize the PK of AMG 420 when administered as 4-week continuous IV infusion Evaluate other measures of anti-myeloma activity of AMG 420: Time to response, PFS, OS, TFI, BOR
primary purpose: Treatment
masking: None (Open Label)
measure: Subject incidence of dose-limiting toxicities
time frame: 4 weeks
description: Evaluate incidence of subjects experiencing dose-limiting toxicities
measure: Subject incidence of treatment emergent adverse events
time frame: 4 weeks
description: Evaluate incidence of subjects experiencing treatment emergent adverse events
measure: Subject incidence of treatment related adverse events
time frame: 4 weeks
description: Evaluate incidence of subjects experiencing treatment related adverse events
measure: Subject incidence of changes in vital signs
time frame: 4 weeks
description: Evaluate incidence of subjects experiencing changes in vital signs
measure: Subject Incidence of Changes in ECGs
time frame: 4 weeks
description: Evaluate incidence of subjects experiencing changes in ECGs
measure: Subject incidence of Changes in clinical laboratory tests
time frame: 4 weeks
description: Evaluate incidence of subjects experiencing changes in clinical laboratory tests
measure: Overall Response Rate
time frame: 6 months
description: Evaluate the rate of subjects responding to treatment with AMG 420
measure: Duration of Response
time frame: 6 months
description: Evaluate the duration of subject responses to treatment with AMG 420
measure: Minimal Residual Disease negativity at the time of CR
time frame: 6 months
description: Evaluate MRD negativity at the time a subject achieves complete response
measure: Half-life
time frame: 4 weeks
description: Half life of AMG 420
measure: Time to response
time frame: 6 months
description: Time to response of AMG 420
measure: Clearance
time frame: 6 months
description: Clearance of AMG 420
measure: Apparent Css
time frame: 6 months
description: Apparent Css of AMG 420
measure: Progression Free Survival (PFS)
time frame: 6 months
description: PFS of AMG 420
measure: Overall Survival
time frame: 6 months
description: OS of of AMG 420
measure: Best Overall Response
time frame: 6 months
description: BOR of AMG 420
measure: Treatment-free Interval
time frame: 6 months
description: TFI of AMG 420
arm group label: AMG 420
arm group type: Experimental
description: Single Arm Design
intervention type: Drug
intervention name: AMG 420
description: 28 day continuous Intravenous infusion of either 400 mcg/d or 600 mcg/d followed by 2 treatment free weeks
arm group label: AMG 420
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Belgium
country: Japan
country: Switzerland
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
ipd url: https://www.amgen.com/datasharing
submitted: March 28, 2023