[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394316":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":49,"centralContacts":50,"locations":56,"responsibleParty":283,"collaborators":49,"id":285,"slug":49,"hasResults":286,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":49,"eligibilityCriteria":290,"healthyVolunteers":286,"sex":291,"minAge":292,"maxAge":49,"enrollmentInfo":293,"targetDuration":49,"studyType":296,"phases":297,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":72,"whyStopped":49,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},{"fullName":5,"class":6},"Karyopharm Therapeutics Inc","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Selinexor + Low-dose Dexamethasone (Sd-40 BIW)","EXPERIMENTAL","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.",[13,14],"Drug: Selinexor","Drug: Dexamethasone",{"label":16,"type":10,"description":17,"interventionNames":18},"Selinexor + Low-dose Dexamethasone (Sd-100 QW)","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 at the discretion of the treating physician).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Selinexor + Low-dose Dexamethasone (Sd-80 BIW)","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. Closed for recruitment.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Selinexor + Bortezomib + Dexamethasone (SVd)","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\u002Fm\\^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 of each week at the discretion of the treating physician). Closed for recruitment.",[13,14,27],"Drug: Bortezomib",[29,37,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Selinexor","Participants will receive Selinexor oral tablets.",[24,16,9,20],[35,36],"KPT-330","XPOVIO",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Dexamethasone","Participants will receive Dexamethasone oral tablets.",[24,16,9,20],[42],"Decadron",{"type":30,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Bortezomib","Participants will receive Bortezomib SC injection.",[24],[48],"Velcade",null,[51],{"name":52,"role":53,"phone":54,"phoneExt":49,"email":55},"Karyopharm Medical Information","CONTACT","(888) 209-9326","clinicaltrials@karyopharm.com",[57,70,88,103,118,134,149,165,177,192,204,219,234,249,265,274],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":49},"University General Hospital of Patras","COMPLETED","Pátrai","Achaia","2654","Greece",{"type":65,"coordinates":66},"Point",[67,68],21.73508,38.2462,{"lat":68,"lon":67},{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":63,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"General Hospital of Athens \"Alexandra\"","RECRUITING","Attiki","Athens","11528",{"type":65,"coordinates":77},[78,79],23.72427,38.00032,{"lat":79,"lon":78},[82,86],{"name":83,"role":53,"phone":84,"phoneExt":49,"email":85},"Prof. Maria Gavriatopoulou","+30 693 413 7080","mariagabria@gmail.com",{"name":83,"role":87,"phone":49,"phoneExt":49,"email":49},"PRINCIPAL_INVESTIGATOR",{"facility":89,"status":72,"city":74,"state":90,"zip":91,"country":63,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"General Hospital of Athens \"Evangelismos\"","Attica","10676",{"type":65,"coordinates":93},[94,95],23.72784,37.98376,{"lat":95,"lon":94},[98,102],{"name":99,"role":53,"phone":100,"phoneExt":49,"email":101},"Dr. Sosana Delimpasi","+30 697 720 4193","sodeli@yahoo.com",{"name":99,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":104,"status":72,"city":105,"state":105,"zip":106,"country":63,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Theageneion Cancer Hospital","Thessaloniki","54007",{"type":65,"coordinates":108},[109,110],22.93493,40.64072,{"lat":110,"lon":109},[113,117],{"name":114,"role":53,"phone":115,"phoneExt":49,"email":116},"Eirini Katoudritou","+30 697 487 2869","eirinikatodritou@gmail.com",{"name":114,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":119,"status":72,"city":120,"state":120,"zip":121,"country":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Emek Medical Center","Afula","1834111","Israel",{"type":65,"coordinates":124},[125,126],35.2892,32.60907,{"lat":126,"lon":125},[129,133],{"name":130,"role":53,"phone":131,"phoneExt":49,"email":132},"Evgeni Chubar","972 52 7828012","Chubar_ev@clalit.org.il",{"name":130,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":135,"status":72,"city":136,"state":136,"zip":137,"country":122,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Assuta Ashdod Medical Center","Ashdod","7747629",{"type":65,"coordinates":139},[140,141],34.64966,31.79213,{"lat":141,"lon":140},[144,148],{"name":145,"role":53,"phone":146,"phoneExt":49,"email":147},"Merav Leiba","972 58 666 9161","meravlei@assuta.co.il",{"name":145,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":150,"status":72,"city":151,"state":152,"zip":153,"country":122,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Bnai-Zion Medical Center","Haifa","Haifa District","3108",{"type":65,"coordinates":155},[156,157],34.99928,32.81303,{"lat":157,"lon":156},[160,164],{"name":161,"role":53,"phone":162,"phoneExt":49,"email":163},"Tamar Tadmor","972506268114","Tamar.tadmor@b-Zion.org.il",{"name":161,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":166,"status":72,"city":151,"state":152,"zip":167,"country":122,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"Rambam Health Care Campus","3109601",{"type":65,"coordinates":169},[156,157],{"lat":157,"lon":156},[172,176],{"name":173,"role":53,"phone":174,"phoneExt":49,"email":175},"Noa Lavi","972 50 206 1332","n_lavi@rambam.health.gov.il",{"name":173,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":178,"status":72,"city":179,"state":179,"zip":180,"country":122,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Shaare Zedek Medical Center","Jerusalem","9103102",{"type":65,"coordinates":182},[183,184],35.21633,31.76904,{"lat":184,"lon":183},[187,191],{"name":188,"role":53,"phone":189,"phoneExt":49,"email":190},"Chezi Ganzel","972-53-3342046","ganzelc@szmc.org.il",{"name":188,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":193,"status":72,"city":179,"state":179,"zip":194,"country":122,"cosmosGeoPoint":195,"geoPoint":197,"contacts":198},"Hadassah Medical Center","9112001",{"type":65,"coordinates":196},[183,184],{"lat":184,"lon":183},[199,203],{"name":200,"role":53,"phone":201,"phoneExt":49,"email":202},"Moshe Gatt","972-505172333","rmoshg@hadassah.org.il",{"name":200,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":205,"status":72,"city":206,"state":206,"zip":207,"country":122,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Rabin Medical Center (Beilinson Hospital)","Petah Tikva","49100",{"type":65,"coordinates":209},[210,211],34.88747,32.08707,{"lat":211,"lon":210},[214,218],{"name":215,"role":53,"phone":216,"phoneExt":49,"email":217},"Amos Cohen","972-50-565-1033","amosc@clalit.org.il",{"name":215,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":220,"status":72,"city":221,"state":221,"zip":222,"country":122,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"The Chaim Sheba Medical Center at Tel HaShomer","Ramat Gan","52621",{"type":65,"coordinates":224},[225,226],34.81065,32.08227,{"lat":226,"lon":225},[229,233],{"name":230,"role":53,"phone":231,"phoneExt":49,"email":232},"Hila Magen","972 50 406 5432","hila.magen@sheba.health.gov.il",{"name":230,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":235,"status":72,"city":236,"state":236,"zip":237,"country":122,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Tel Aviv Sourasky Medical Center","Tel Aviv","64239",{"type":65,"coordinates":239},[240,241],34.78057,32.08088,{"lat":241,"lon":240},[244,248],{"name":245,"role":53,"phone":246,"phoneExt":49,"email":247},"Yael Cohen","972 52 662 2575","yaelcoh@tlvmc.gov.il",{"name":245,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":250,"status":72,"city":251,"state":49,"zip":252,"country":122,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Barzilai Medical Center","Ashkelon","7830604",{"type":65,"coordinates":254},[255,256],34.57149,31.66926,{"lat":256,"lon":255},[259,261,264],{"name":260,"role":53,"phone":49,"phoneExt":49,"email":49},"Anatoly Nemets, MD",{"name":49,"role":53,"phone":262,"phoneExt":49,"email":263},"972 8 6745796","anatolyn@bmc.gov.il",{"name":260,"role":87,"phone":49,"phoneExt":49,"email":49},{"facility":266,"status":267,"city":268,"state":49,"zip":49,"country":122,"cosmosGeoPoint":269,"geoPoint":273,"contacts":49},"Soroka University Medical Center","ACTIVE_NOT_RECRUITING","Beersheba",{"type":65,"coordinates":270},[271,272],34.7913,31.25181,{"lat":272,"lon":271},{"facility":275,"status":59,"city":276,"state":49,"zip":277,"country":122,"cosmosGeoPoint":278,"geoPoint":282,"contacts":49},"Meir Medical Center","Kfar Saba","4428164",{"type":65,"coordinates":279},[280,281],34.90694,32.175,{"lat":281,"lon":280},{"type":284,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100394316",false,"NCT04414475","A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.","A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age greater than or equal to (\\>=)18 years at the time of signing informed consent.\n* Written informed consent in accordance with federal, local, and institutional guidelines.\n* Measurable MM based on IMWG guidelines as defined by at least one of the following:\n\n  1. Serum M-protein \\>= 0.5 gram per deciliter (g\u002FdL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.\n  2. Urinary M-protein excretion \\>= 200 mg\u002F24 hours.\n  3. Free light chain (FLC) \\>= 100 milligram per liter (mg\u002FL), provided that the FLC ratio is abnormal.\n* Only for arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to protocol version (PV) 5.0: Participants must have relapsed or refractory multiple myeloma (RRMM) and have previously received at least 4 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 2 proteasome inhibitors (PIs), at least 2 immunomodulatory agent (IMiDs), and 1 anti-cluster of differentiation (CD38) monoclonal antibody. Refractory is defined as lesser than or equal to (\\\u003C=) 25 percent (%) response to therapy, or progression during therapy or progression within 60 days after completion of therapy.\n* Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Participants must have RR MM and have been previously treated with \\>=3 anti-MM therapies (with exposure to at least 2 PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractory to at least 1 drug of each class (PI\u002FIMiD\u002Fanti-CD38). Refractory is defined as \\\u003C=25% response to therapy or progression during therapy or progression within 60 days after completion of therapy.\n* Only for arm SVd: Participants must have previously received 1 to 5 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 1 PI, at least 1 IMiD, and 1 anti- CD38 monoclonal antibody.\n* Eastern Cooperative Oncology Group (ECOG) performance status of \\\u003C= 2.\n* Female participants of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 7 months for female and 4 months for male following the discontinuation of study treatment.\n\nExclusion Criteria:\n\n* Active plasma cell leukemia.\n* Documented systemic amyloid light chain amyloidosis.\n* Active central nervous system MM.\n* Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade \\>= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the participant is currently receiving medication.\n* Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (including investigational therapies) \\\u003C= 2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids are permitted up to 1 pulse of 40 mg per day for 4 days in the 2 weeks prior to C1D1).\n* Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.\n* Ongoing clinically significant non-hematological toxicities from prior treatments that are Grade greater than (\\>) 2 at C1D1.\n* Inadequate hepatic function defined as total bilirubin \\>= 2x upper limit of normal (ULN) (\\>= 3x ULN for participants with Gilbert's syndrome), aspartate transaminase (AST) \\>= 2.5x ULN, and alanine transaminase (ALT) \\>= 2.5x ULN.\n* Inadequate renal function defined as estimated creatinine clearance of lesser than (\\\u003C) 20 milliliter per minute (mL\u002Fmin), calculated using the formula of Cockroft and Gault.\n* Inadequate hematopoietic function defined as the following:\n\n  1. Absolute neutrophil count (ANC) \\\u003C 1000\u002Fcubic millimeter (mm\\^3)\n  2. Platelet count \\\u003C 75,000\u002Fmm\\^3\n  3. Hemoglobin (Hb) level \\\u003C 8.5 g\u002FdL\n* Life expectancy of \\\u003C 4 months, based on the opinion of the Investigator.\n* Major surgery within 4 weeks prior to C1D1.\n* Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose.\n* Active gastrointestinal dysfunction interfering with the ability to swallow tablets, or any gastrointestinal dysfunction that could interfere with absorption of the study treatment.\n* Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus RNA or hepatitis B virus surface antigen.\n* Female participants who are pregnant or lactating.\n* Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapy at C1D1.\n* Concurrent therapy with approved or investigational anticancer therapeutic including topical therapies.\n* Prior exposure to a SINE compound, including selinexor.\n* Serious, active psychiatric or active medical conditions which, in the opinion of the Investigator or the Sponsor, could interfere with the participation in the study.\n* Contraindication to any of the required concomitant drugs or supportive treatments.","ALL","18 Years",{"count":294,"type":295},127,"ESTIMATED","INTERVENTIONAL",[298],"PHASE2","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.",[301],"Multiple Myeloma, Refractory",[303,31,304,305,35],"Multiple Myeloma","Penta-refractory Multiple Myeloma","Triple-class Refractory Multiple Myeloma","2026-01-30",{"date":308,"type":309},"2026-02-02","ACTUAL",{"date":311,"type":309},"2020-07-01",{"date":313,"type":295},"2028-01",{"name":5,"class":6},16]