<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/NCT04414475</url>
  </required_header>
  <id_info>
    <org_study_id>XPORT-MM-028</org_study_id>
    <nct_id>NCT04414475</nct_id>
  </id_info>
  <brief_title>A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM, and Seli and Pomalidomide + LDD in Relapsed Refractory MM</brief_title>
  <official_title>A Phase 2b, Open-label Study of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma (MM), Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory MM, and Selinexor and Pomalidomide Plus Low-dose Dexamethasone (SPd) in Patients With Relapsed Refractory MM.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karyopharm Therapeutics Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karyopharm Therapeutics Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy, antitumor activity, safety and&#xD;
      tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory&#xD;
      multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with&#xD;
      triple-class refractory multiple myeloma or selinexor and pomalidomide plus low-dose&#xD;
      dexamethasone in participants with relapsed and/or refractory multiple myeloma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>From the date of randomization up to death (approximately 14 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>From the date of randomization to first disease progression or death (approximately 14 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR)</measure>
    <time_frame>From the date of randomization up to death (approximately 14 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>From the date of randomization up to death (approximately 14 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>From the date of randomization to first disease progression or death (approximately 14 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From the date of randomization up to death (approximately 14 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Treatment (TTNT)</measure>
    <time_frame>From the date of first dose up to death (approximately 14 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events (AE)</measure>
    <time_frame>From start of study drug administration up to follow-up (approximately 3 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">141</enrollment>
  <condition>Multiple Myeloma, Refractory</condition>
  <arm_group>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-40 BIW)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fixed dose of 40 milligram (mg) of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet twice weekly (BIW) on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-100 QW)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fixed dose of 100 mg of Selinexor oral tablet followed by 40 mg of low-dose Dexamethasone oral tablet once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone may be given as 20 mg on days 1 and 2 of each week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-80 BIW)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fixed dose of 80 mg of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet BIW on Days 1, 3, 8, 10,15, 17, 22, and 24 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selinexor + Bortezomib + Dexamethasone (SVd)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fixed dose of 100 mg of Selinexor oral tablet on Days 1, 8, 15, 22, and 29 followed by 1.3 milligram per square-meter (mg/m^2) of Bortezomib subcutaneous (SC) injection on Days 1, 8, 15, and 22 and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, 22, and 29 of each 35-day cycle (Dexamethasone dose may be split to 20 mg on days 1 and 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selinexor + Pomalidomide + Dexamethasone (SPd)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fixed dose of 40 mg of Selinexor oral tablet on Days 1, 8, 15, and 22 of each 28-day cycle followed by Pomalidomide 4 mg PO on Days 1 through 21 of each 28-day cycle and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone dose 20 mg QW for those of &gt;75 years old at the Investigator's discretion, before QW dosing of Selinexor; it may be divided over 1 to 4 days at the Investigator's discretion).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor</intervention_name>
    <description>Participants will receive Selinexor oral tablets.</description>
    <arm_group_label>Selinexor + Bortezomib + Dexamethasone (SVd)</arm_group_label>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-100 QW)</arm_group_label>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-40 BIW)</arm_group_label>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-80 BIW)</arm_group_label>
    <arm_group_label>Selinexor + Pomalidomide + Dexamethasone (SPd)</arm_group_label>
    <other_name>KPT-330</other_name>
    <other_name>XPOVIO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Participants will receive Dexamethasone oral tablets.</description>
    <arm_group_label>Selinexor + Bortezomib + Dexamethasone (SVd)</arm_group_label>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-100 QW)</arm_group_label>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-40 BIW)</arm_group_label>
    <arm_group_label>Selinexor + Low-dose Dexamethasone (Sd-80 BIW)</arm_group_label>
    <arm_group_label>Selinexor + Pomalidomide + Dexamethasone (SPd)</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib</intervention_name>
    <description>Participants will receive Bortezomib SC injection.</description>
    <arm_group_label>Selinexor + Bortezomib + Dexamethasone (SVd)</arm_group_label>
    <other_name>Velcade</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Participants will receive Pomalidomide oral tablets.</description>
    <arm_group_label>Selinexor + Pomalidomide + Dexamethasone (SPd)</arm_group_label>
    <other_name>Imnovid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to (≥)18 years at the time of signing informed consent.&#xD;
&#xD;
          -  Written informed consent in accordance with federal, local, and institutional&#xD;
             guidelines.&#xD;
&#xD;
          -  Measurable MM based on IMWG guidelines as defined by at least one of the following:&#xD;
&#xD;
               1. Serum M-protein ≥ 0.5 gram per deciliter (g/dL) by serum protein electrophoresis&#xD;
                  (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.&#xD;
&#xD;
               2. Urinary M-protein excretion ≥ 200 mg/24 hours.&#xD;
&#xD;
               3. Free light chain (FLC) ≥ 100 milligram per liter (mg/L), provided that the FLC&#xD;
                  ratio is abnormal.&#xD;
&#xD;
          -  Only for arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW: Participants must have relapsed or&#xD;
             refractory multiple myeloma (RRMM) and have previously received at least 4 anti-MM&#xD;
             prior therapies and have MM that is refractory to previous treatment with at least 2&#xD;
             proteasome inhibitors (PIs), at least 2 immunomodulatory agent (IMiDs), and 1&#xD;
             anti-cluster of differentiation (CD38) monoclonal antibody. Refractory is defined as&#xD;
             lesser than or equal to (≤) 25 percent (%) response to therapy, or progression during&#xD;
             therapy or progression within 60 days after completion of therapy.&#xD;
&#xD;
          -  Only for arm SVd: Participants must have previously received 1 to 5 anti-MM prior&#xD;
             therapies and have MM that is refractory to previous treatment with at least 1 PI, at&#xD;
             least 1 IMiD, and 1 anti- CD38 monoclonal antibody.&#xD;
&#xD;
          -  Only for arm SPd: relapsed or refractory pomalidomide naïve MM with: documented&#xD;
             evidence of progressive disease (PD) after achieving at least SD for ≥1 cycle during a&#xD;
             previous MM regimen (i.e., relapsed MM); ≤25% response (i.e., patients never achieved&#xD;
             ≥MR) or PD during or within 60 days from the end of the most recent MM regimen (i.e.,&#xD;
             refractory MM); previously undergone ≥2 cycles of lenalidomide and a PI (in separate&#xD;
             therapeutic regimens [not for maintenance] or in combination).&#xD;
&#xD;
          -  Only for arm SPd: only patients that were prescribed with pomalidomide as per standard&#xD;
             of care will be enrolled in this arm at the discretion of the Investigators.&#xD;
&#xD;
          -  Only for arm SPd: adequate hematopoietic function within 28 days prior to C1D1: total&#xD;
             white blood cell (WBC) count ≥1,500/mm³, ANC ≥1,000/mm³, hemoglobin (Hb) ≥8.0 g/dL,&#xD;
             Platelet count ≥100,000/mm³&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.&#xD;
&#xD;
          -  Female participants of childbearing potential must agree to use dual methods of&#xD;
             contraception and have a negative serum pregnancy test at screening, and male&#xD;
             participants must use an effective barrier method of contraception if sexually active&#xD;
             with a female of childbearing potential. For both male and female participants,&#xD;
             effective methods of contraception must be used throughout the study and for 7 months&#xD;
             for female and 4 months for male following the discontinuation of study treatment.&#xD;
&#xD;
          -  Participants agrees to provide bone marrow aspirate to be used for genetic testing of&#xD;
             participants agrees to provide bone marrow aspirate to be used for genetic testing of&#xD;
             deoxyribonucleic acid (DNA) and ribonucleic acid (RNA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active plasma cell leukemia.&#xD;
&#xD;
          -  Documented systemic amyloid light chain amyloidosis.&#xD;
&#xD;
          -  Active central nervous system MM.&#xD;
&#xD;
          -  Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral&#xD;
             neuropathy with pain at baseline, regardless of whether or not the participant is&#xD;
             currently receiving medication.&#xD;
&#xD;
          -  Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (including&#xD;
             investigational therapies) ≤ 2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids are&#xD;
             permitted up to 1 pulse of 40 mg per day for 4 days in the 2 weeks prior to C1D1).&#xD;
&#xD;
          -  Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.&#xD;
&#xD;
          -  Ongoing clinically significant non-hematological toxicities from prior treatments that&#xD;
             are Grade greater than (&gt;) 2 at C1D1.&#xD;
&#xD;
          -  Inadequate hepatic function defined as total bilirubin ≥ 2x upper limit of normal&#xD;
             (ULN) (≥ 3x ULN for participants with Gilbert's syndrome), aspartate transaminase&#xD;
             (AST) ≥ 2.5x ULN, and alanine transaminase (ALT) ≥ 2.5x ULN.&#xD;
&#xD;
          -  Inadequate renal function defined as estimated creatinine clearance of lesser than (&lt;)&#xD;
             20 milliliter per minute (mL/min), calculated using the formula of Cockroft and Gault.&#xD;
&#xD;
          -  Inadequate hematopoietic function defined as the following:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) &lt; 1000/cubic millimeter (mm³)&#xD;
&#xD;
               2. Platelet count &lt; 75,000/mm³&#xD;
&#xD;
               3. Hemoglobin (Hb) level &lt; 8.5 g/dL&#xD;
&#xD;
          -  Life expectancy of &lt; 4 months, based on the opinion of the Investigator.&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to C1D1.&#xD;
&#xD;
          -  Uncontrolled active infection requiring parenteral antibiotics, antivirals, or&#xD;
             antifungals within 1 week prior to first dose.&#xD;
&#xD;
          -  Active gastrointestinal dysfunction interfering with the ability to swallow tablets,&#xD;
             or any gastrointestinal dysfunction that could interfere with absorption of the study&#xD;
             treatment.&#xD;
&#xD;
          -  Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C&#xD;
             virus RNA or hepatitis B virus surface antigen.&#xD;
&#xD;
          -  Receipt of red blood cells (RBC) transfusions within 2 weeks of C1D1.&#xD;
&#xD;
          -  Receipt of platelet transfusion within 1 week of C1D1.&#xD;
&#xD;
          -  Receipt of the following blood growth factors within 2 weeks prior to C1D1:&#xD;
             Granulocyte colony stimulating factor, granulocyte-macrophage colony stimulating&#xD;
             factor, erythropoietin, or megakaryocyte growth factor.&#xD;
&#xD;
          -  Female participants who are pregnant or lactating.&#xD;
&#xD;
          -  Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapy at&#xD;
             C1D1.&#xD;
&#xD;
          -  Concurrent therapy with approved or investigational anticancer therapeutic including&#xD;
             topical therapies.&#xD;
&#xD;
          -  Prior exposure to a SINE compound, including selinexor.&#xD;
&#xD;
          -  Serious, active psychiatric or active medical conditions which, in the opinion of the&#xD;
             Investigator or the Sponsor, could interfere with the participation in the study.&#xD;
&#xD;
          -  Contraindication to any of the required concomitant drugs or supportive treatments.&#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_contact>
    <last_name>Karyopharm Medical Information</last_name>
    <phone>(888) 209-9326</phone>
    <email>clinicaltrials@karyopharm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University General Hospital of Patras</name>
      <address>
        <city>Patra</city>
        <state>Achaia</state>
        <zip>2654</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Anargyros Symeonidis</last_name>
      <phone>+30 694 496 0012</phone>
      <email>argiris.symeonidis@yahoo.gr</email>
    </contact>
    <investigator>
      <last_name>Prof. Anargyros Symeonidis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;ALEXANDRA&quot;</name>
      <address>
        <city>Attiki</city>
        <state>Athens</state>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Maria Gavriatopoulou</last_name>
      <phone>+30 693 413 7080</phone>
      <email>mariagabria@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Prof. Maria Gavriatopoulou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Evaggelismos&quot;</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Sosana Delimpasi</last_name>
      <phone>+30 697 720 4193</phone>
      <email>sodeli@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Dr. Sosana Delimpasi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Theageneion Cancer Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54007</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eirini Katoudritou</last_name>
      <phone>+30 697 487 2869</phone>
      <email>eirinikatodritou@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Eirini Katoudritou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emek Medical Center</name>
      <address>
        <city>Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evgeni Chubar</last_name>
      <phone>972 52 7828012</phone>
      <email>Chubar_ev@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Evgeni Chubar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Assuta Ashdod Medical Center</name>
      <address>
        <city>Ashdod</city>
        <zip>7747629</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Merav Leiba</last_name>
      <phone>972 58 666 9161</phone>
      <email>meravlei@assuta.co.il</email>
    </contact>
    <investigator>
      <last_name>Merav Leiba</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>7830604</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anatoly Nemets, MD</last_name>
    </contact>
    <contact_backup>
      <phone>972 8 6745796</phone>
      <email>anatolyn@bmc.gov.il</email>
    </contact_backup>
    <investigator>
      <last_name>Anatoly Nemets, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Beer-Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bnai-Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3108</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tamar Tadmor</last_name>
      <phone>972506268114</phone>
      <email>Tamar.tadmor@b-Zion.org.il</email>
    </contact>
    <investigator>
      <last_name>Tamar Tadmor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noa Lavi</last_name>
      <phone>972 50 206 1332</phone>
      <email>n_lavi@rambam.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Noa Lavi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chezi Ganzel</last_name>
      <phone>972-53-3342046</phone>
      <email>ganzelc@szmc.org.il</email>
    </contact>
    <investigator>
      <last_name>Chezi Ganzel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moshe Gatt</last_name>
      <phone>972-505172333</phone>
      <email>rmoshg@hadassah.org.il</email>
    </contact>
    <investigator>
      <last_name>Moshe Gatt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Osnat Jarchowsky, MD</last_name>
      <email>osnat.JARCHOWSKY@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Osnat Jarchowsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center (Beilinson Hospital)</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amos Cohen</last_name>
      <phone>972-50-565-1033</phone>
      <email>amosc@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Amos Cohen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center at Tel HaShomer</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hila Magen</last_name>
      <phone>972 50 406 5432</phone>
      <email>hila.magen@sheba.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Hila Magen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yael Cohen</last_name>
      <phone>972 52 662 2575</phone>
      <email>yaelcoh@tlvmc.gov.il</email>
    </contact>
    <investigator>
      <last_name>Yael Cohen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Selinexor</keyword>
  <keyword>Penta-refractory Multiple Myeloma</keyword>
  <keyword>Triple-class Refractory Multiple Myeloma</keyword>
  <keyword>KPT-330</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04414475
org study id: XPORT-MM-028
nct id: NCT04414475
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the efficacy, antitumor activity, safety and
      tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory
      multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with
      triple-class refractory multiple myeloma or selinexor and pomalidomide plus low-dose
      dexamethasone in participants with relapsed and/or refractory multiple myeloma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: From the date of randomization up to death (approximately 14 months)
measure: Duration of Response (DOR)
time frame: From the date of randomization to first disease progression or death (approximately 14 months)
measure: Clinical Benefit Rate (CBR)
time frame: From the date of randomization up to death (approximately 14 months)
measure: Disease control rate (DCR)
time frame: From the date of randomization up to death (approximately 14 months)
measure: Progression-Free Survival (PFS)
time frame: From the date of randomization to first disease progression or death (approximately 14 months)
measure: Overall Survival (OS)
time frame: From the date of randomization up to death (approximately 14 months)
measure: Time to Next Treatment (TTNT)
time frame: From the date of first dose up to death (approximately 14 months)
measure: Number of Participants with Adverse Events (AE)
time frame: From start of study drug administration up to follow-up (approximately 3 months)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
arm group type: Experimental
description: Participants will receive fixed dose of 40 milligram (mg) of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet twice weekly (BIW) on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle.
arm group label: Selinexor + Low-dose Dexamethasone (Sd-100 QW)
arm group type: Experimental
description: Participants will receive fixed dose of 100 mg of Selinexor oral tablet followed by 40 mg of low-dose Dexamethasone oral tablet once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone may be given as 20 mg on days 1 and 2 of each week).
arm group label: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
arm group type: Experimental
description: Participants will receive fixed dose of 80 mg of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet BIW on Days 1, 3, 8, 10,15, 17, 22, and 24 of each 28-day cycle.
arm group label: Selinexor + Bortezomib + Dexamethasone (SVd)
arm group type: Experimental
description: Participants will receive fixed dose of 100 mg of Selinexor oral tablet on Days 1, 8, 15, 22, and 29 followed by 1.3 milligram per square-meter (mg/m^2) of Bortezomib subcutaneous (SC) injection on Days 1, 8, 15, and 22 and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, 22, and 29 of each 35-day cycle (Dexamethasone dose may be split to 20 mg on days 1 and 2).
arm group label: Selinexor + Pomalidomide + Dexamethasone (SPd)
arm group type: Experimental
description: Participants will receive fixed dose of 40 mg of Selinexor oral tablet on Days 1, 8, 15, and 22 of each 28-day cycle followed by Pomalidomide 4 mg PO on Days 1 through 21 of each 28-day cycle and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone dose 20 mg QW for those of >75 years old at the Investigator's discretion, before QW dosing of Selinexor; it may be divided over 1 to 4 days at the Investigator's discretion).
intervention type: Drug
intervention name: Selinexor
description: Participants will receive Selinexor oral tablets.
arm group label: Selinexor + Bortezomib + Dexamethasone (SVd)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-100 QW)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
arm group label: Selinexor + Pomalidomide + Dexamethasone (SPd)
other name: KPT-330
other name: XPOVIO
intervention type: Drug
intervention name: Dexamethasone
description: Participants will receive Dexamethasone oral tablets.
arm group label: Selinexor + Bortezomib + Dexamethasone (SVd)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-100 QW)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
arm group label: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
arm group label: Selinexor + Pomalidomide + Dexamethasone (SPd)
other name: Decadron
intervention type: Drug
intervention name: Bortezomib
description: Participants will receive Bortezomib SC injection.
arm group label: Selinexor + Bortezomib + Dexamethasone (SVd)
other name: Velcade
intervention type: Drug
intervention name: Pomalidomide
description: Participants will receive Pomalidomide oral tablets.
arm group label: Selinexor + Pomalidomide + Dexamethasone (SPd)
other name: Imnovid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karyopharm Medical Information
phone: (888) 209-9326
email: clinicaltrials@karyopharm.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
country: Israel
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Bortezomib
mesh term: Pomalidomide
sharing ipd: Undecided