<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/NCT03287908</url>
  </required_header>
  <id_info>
    <org_study_id>20170122</org_study_id>
    <secondary_id>2017-001997-41</secondary_id>
    <nct_id>NCT03287908</nct_id>
  </id_info>
  <brief_title>A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma</brief_title>
  <official_title>A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination With Pomalidomide, With and Without Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)</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>
      The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability&#xD;
      of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a&#xD;
      dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in&#xD;
      adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will&#xD;
      include a sequential dose exploration part to identify the RP2D of AMG 701 in combination&#xD;
      with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of&#xD;
      the dose-expansion part to gain further efficacy and safety experience with AMG 701&#xD;
      monotherapy in adult subjects with RRMM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    business decision, not safety reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with dose-limiting toxicities (DLTs)</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with treatment emergent adverse events (TEAEs)</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with treatment-related adverse events</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with disease-related adverse events</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically-significant changes in vital signs</measure>
    <time_frame>48 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically-significant changes in physical examination measurements</measure>
    <time_frame>48 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically-significant changes in electrocardiogram (ECG) measurements</measure>
    <time_frame>48 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically-significant changes in clinical laboratory tests</measure>
    <time_frame>48 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter of AMG 701: Maximum concentration (Cmax)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter of AMG 701: Time of maximum concentration (Tmax)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter of AMG 701: Area under the concentration-time curve (AUC)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter of AMG 701: Steady state concentration (Css)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Overall response rate</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Best overall response of stringent CR (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Best overall response of stringent complete response (sCR)</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Best overall response of complete response (CR)</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Best overall response of very good partial response (VGPR)</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Best overall response of partial response (PR)</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Duration of response</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from the first PR or better to disease progression or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Time to response</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Progression-free survival</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from start of treatment until disease progression or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Overall survival</measure>
    <time_frame>60 months</time_frame>
    <description>Defined as time from start of treatment until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity: Number of subjects with minimum residual disease negative complete response</measure>
    <time_frame>48 months</time_frame>
    <description>Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter of AMG 701: Trough concentration (Ctrough)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Relapsed/Refractory Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>AMG 701</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AMG 701 + Pomalidomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AMG 701 + Pomalidomide + Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 701</intervention_name>
    <description>Subjects will receive IV infusions of AMG 701.</description>
    <arm_group_label>AMG 701</arm_group_label>
    <arm_group_label>AMG 701 + Pomalidomide</arm_group_label>
    <arm_group_label>AMG 701 + Pomalidomide + Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Subjects will receive oral capsules of pomalidomide.</description>
    <arm_group_label>AMG 701 + Pomalidomide</arm_group_label>
    <arm_group_label>AMG 701 + Pomalidomide + Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Subjects will receive IV injections or oral dexamethasone.</description>
    <arm_group_label>AMG 701 + Pomalidomide + Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Multiple myeloma meeting the following criteria:&#xD;
&#xD;
               -  Pathologically-documented diagnosis of multiple myeloma that is relapsed or is&#xD;
                  refractory as defined by the following:&#xD;
&#xD;
                    -  Relapsed after &gt; or = 3 lines of prior therapy that must include all&#xD;
                       approved and available therapies deemed eligible by the investigator,&#xD;
                       inclusing at a minimum of a proteasome inhibitor (PI), an immunomodulatory&#xD;
                       drug (IMiD), and, where approved and available, a CD38-directed cytolytic&#xD;
                       antibody in combination in the same line or separate lines of treatment OR&#xD;
                       refractory to PI, IMiD, and CD38- directed cytolytic antibody,&#xD;
&#xD;
                    -  Subjects who could not tolerate a PI, IMiDs, or a CD38-directed cytolytic&#xD;
                       antibody are eligible to enroll in the study.&#xD;
&#xD;
               -  Measurable disease as per IMWG response criteria&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2&#xD;
&#xD;
        Inclusion criteria specific to AMG 701-P±d include:&#xD;
&#xD;
          -  Subjects must have received ≥ 2 lines of prior therapy that must include a proteasome&#xD;
             inhibitor (PI), lenalidomide, and where approved and available a CD38-directed&#xD;
             antibody. These therapies may be in the same line or separate lines of treatment.&#xD;
&#xD;
          -  Subjects must have responded to at least 1 prior line with at least a PR.&#xD;
&#xD;
          -  Subjects that have previously received pomalidomide must not have been removed from&#xD;
             therapy due to toxicity attributable to pomalidomide and must be at least 6 months&#xD;
             from their last dose of pomalidomide.&#xD;
&#xD;
          -  Subjects must not have known intolerance to doses of dexamethasone up to 40 mg weekly&#xD;
             (20 mg weekly if &gt; 75 years).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known extramedullary relapse in the absence of any measurable medullary involvement&#xD;
&#xD;
          -  Known central nervous system involvement by multiple myeloma&#xD;
&#xD;
          -  Autologous stem cell transplantation less than 90 days prior to study day 1&#xD;
&#xD;
          -  Recent history of primary plasma cell leukemia (within last 6 months prior to&#xD;
             enrollment) or evidence of primary or secondary plasma cell leukemia at the time of&#xD;
             screening&#xD;
&#xD;
          -  Waldenstrom's macroglobulinemia&#xD;
&#xD;
          -  Prior amyloidosis (subjects with multiple myeloma with asymptomatic deposition of&#xD;
             amyloid plaques found on biopsy would be eligible if all other criteria are met)&#xD;
&#xD;
          -  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;
          -  Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) &lt; 2&#xD;
             weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks&#xD;
             prior to study day 1 as well as systemic radiation therapy within 28 days prior to&#xD;
             study day 1 or focal radiotherapy within 14 days prior to study day 1.&#xD;
&#xD;
          -  Prior treatment with any drug or construct that targets BCMA on tumor cells (eg, other&#xD;
             bispecific antibody constructs, antibody drug conjugates, or CAR-T cells), other than&#xD;
             Group C where prior treatment with GSK2857916 (belantamab mafodotin) is required.&#xD;
&#xD;
        Exclusion criteria specific to AMG 701-P±d include:&#xD;
&#xD;
          -  History of serious hypersensitivity associated with thalidomide, pomalidomide, or&#xD;
             lenalidomide (&gt; grade 3).&#xD;
&#xD;
          -  Multiple myeloma with IgM subtype.&#xD;
&#xD;
          -  POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and&#xD;
             skin changes).&#xD;
&#xD;
          -  Contraindication to pomalidomide or dexamethasone.&#xD;
&#xD;
          -  Glucocorticoid therapy within 14 days prior to randomization that exceeds a cumulative&#xD;
             dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids.&#xD;
&#xD;
          -  Treatment with systemic immune modulators including, but not limited to, non-topical&#xD;
             systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent),&#xD;
             cyclosporine, and tacrolimus within 2 weeks before study day 1 or 4 weeks before study&#xD;
             day 1 for Phase 1 dose-confirmation.&#xD;
&#xD;
          -  Female subjects of childbearing potential with a positive pregnancy test assessed&#xD;
             within 14 days prior to first dose of study drugs and/or a positive urine pregnancy&#xD;
             test within 24 hours prior to first dose. In addition, females of childbearing&#xD;
             potential unwilling to undergo pregnancy testing weekly during the first 4 weeks of&#xD;
             pomalidomide use followed by pregnancy testing every 4 weeks in females with regular&#xD;
             menses or every 2 weeks in females with irregular menstrual cycles.&#xD;
&#xD;
          -  Male subjects with a female partner of childbearing potential and female subjects of&#xD;
             childbearing potential who are unwilling to use 2 methods of contraception (1 of which&#xD;
             must be highly effective during the study and for an additional 75 days (females) and&#xD;
             135 days (males) after receiving the last dose of AMG 701, or 28 days after the last&#xD;
             dose pomalidomide (males and females) or dexamethasone (females), whichever occurs&#xD;
             later.&#xD;
&#xD;
          -  Females who are lactating/breastfeeding or who plan to breastfeed while on study&#xD;
             through 75 days after receiving the last dose of AMG 701, or 28 days after the last&#xD;
             dose pomalidomide or dexamethasone, whichever occurs later.&#xD;
&#xD;
          -  Females planning to become pregnant while on study through 75 days after receiving the&#xD;
             last dose of AMG 701 or 28 days after the last dose pomalidomide or dexamethasone,&#xD;
             whichever occurs later.&#xD;
&#xD;
          -  Male subjects with a pregnant partner who are unwilling to practice abstinence or use&#xD;
             a latex or synthetic condom (even if they have had a vasectomy with medical&#xD;
             confirmation of surgical success) during treatment (including during dose&#xD;
             interruptions) and for an additional 135 days after the last dose of AMG 701, or 28&#xD;
             days after the last dose pomalidomide, whichever occurs later.&#xD;
&#xD;
          -  Males who are unwilling to abstain from sperm donation while on study through 135 days&#xD;
             after receiving the last dose of AMG 701 or 28 days after the last dose pomalidomide,&#xD;
             whichever occurs later.&#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>Mayo Clinic - Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences Myeloma Institute Slot 816</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute Emory U</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center - Multiple Myeloma Research Consortium</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital, Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</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>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network-Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre Glen Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig Holstein Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Wuerzburg</name>
      <address>
        <city>Wuerzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Maebashi-shi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</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>The Cancer Institute Hospital of Japanese Foundation for Cancer Research</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Amgen</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Phase 2</keyword>
  <keyword>Phase 1/2</keyword>
  <keyword>Clinical Trial</keyword>
  <keyword>Oncology/Hematology</keyword>
  <keyword>Relapsed/Refractory Multiple Myeloma</keyword>
  <keyword>Immunotherapy</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>Pomalidomide</mesh_term>
  </intervention_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>
  <!-- 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/NCT03287908
org study id: 20170122
secondary id: 2017-001997-41
nct id: NCT03287908
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability
      of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a
      dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in
      adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will
      include a sequential dose exploration part to identify the RP2D of AMG 701 in combination
      with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of
      the dose-expansion part to gain further efficacy and safety experience with AMG 701
      monotherapy in adult subjects with RRMM.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects with dose-limiting toxicities (DLTs)
time frame: 28 days
measure: Number of subjects with treatment emergent adverse events (TEAEs)
time frame: 60 months
measure: Number of subjects with treatment-related adverse events
time frame: 60 months
measure: Number of subjects with disease-related adverse events
time frame: 60 months
measure: Number of subjects with clinically-significant changes in vital signs
time frame: 48 months
measure: Number of subjects with clinically-significant changes in physical examination measurements
time frame: 48 months
measure: Number of subjects with clinically-significant changes in electrocardiogram (ECG) measurements
time frame: 48 months
measure: Number of subjects with clinically-significant changes in clinical laboratory tests
time frame: 48 months
measure: Pharmacokinetic parameter of AMG 701: Maximum concentration (Cmax)
time frame: 12 weeks
measure: Pharmacokinetic parameter of AMG 701: Time of maximum concentration (Tmax)
time frame: 12 weeks
measure: Pharmacokinetic parameter of AMG 701: Area under the concentration-time curve (AUC)
time frame: 12 weeks
measure: Pharmacokinetic parameter of AMG 701: Steady state concentration (Css)
time frame: 12 weeks
measure: Anti-tumor activity: Overall response rate
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Best overall response of stringent CR (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
measure: Anti-tumor activity: Best overall response of stringent complete response (sCR)
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
measure: Anti-tumor activity: Best overall response of complete response (CR)
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
measure: Anti-tumor activity: Best overall response of very good partial response (VGPR)
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
measure: Anti-tumor activity: Best overall response of partial response (PR)
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
measure: Anti-tumor activity: Duration of response
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from the first PR or better to disease progression or death.
measure: Anti-tumor activity: Time to response
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
measure: Anti-tumor activity: Progression-free survival
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from start of treatment until disease progression or death.
measure: Anti-tumor activity: Overall survival
time frame: 60 months
description: Defined as time from start of treatment until death due to any cause.
measure: Anti-tumor activity: Number of subjects with minimum residual disease negative complete response
time frame: 48 months
description: Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
measure: Pharmacokinetic parameter of AMG 701: Trough concentration (Ctrough)
time frame: 12 weeks
arm group label: AMG 701
arm group type: Experimental
arm group label: AMG 701 + Pomalidomide
arm group type: Experimental
arm group label: AMG 701 + Pomalidomide + Dexamethasone
arm group type: Experimental
intervention type: Drug
intervention name: AMG 701
description: Subjects will receive IV infusions of AMG 701.
arm group label: AMG 701
arm group label: AMG 701 + Pomalidomide
arm group label: AMG 701 + Pomalidomide + Dexamethasone
intervention type: Drug
intervention name: Pomalidomide
description: Subjects will receive oral capsules of pomalidomide.
arm group label: AMG 701 + Pomalidomide
arm group label: AMG 701 + Pomalidomide + Dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Subjects will receive IV injections or oral dexamethasone.
arm group label: AMG 701 + Pomalidomide + Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Canada
country: Germany
country: Japan
country: Netherlands
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
mesh term: Dexamethasone
mesh term: Pomalidomide
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