[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394316":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":49,"centralContacts":50,"locations":56,"responsibleParty":285,"collaborators":49,"id":287,"slug":288,"hasResults":289,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":49,"eligibilityCriteria":293,"healthyVolunteers":289,"sex":294,"minAge":295,"maxAge":49,"enrollmentInfo":296,"targetDuration":49,"studyType":299,"phases":300,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":73,"whyStopped":49,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},{"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",[57,71,89,104,119,136,151,167,179,194,206,221,236,251,267,276],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":49},"University General Hospital of Patras","COMPLETED","Pátrai","Achaia","2654","Greece","GR",{"type":66,"coordinates":67},"Point",[68,69],21.73508,38.2462,{"lat":69,"lon":68},{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":63,"countryCode":64,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"General Hospital of Athens \"Alexandra\"","RECRUITING","Attiki","Athens","11528",{"type":66,"coordinates":78},[79,80],23.72427,38.00032,{"lat":80,"lon":79},[83,87],{"name":84,"role":53,"phone":85,"phoneExt":49,"email":86},"Prof. Maria Gavriatopoulou","+30 693 413 7080","mariagabria@gmail.com",{"name":84,"role":88,"phone":49,"phoneExt":49,"email":49},"PRINCIPAL_INVESTIGATOR",{"facility":90,"status":73,"city":75,"state":91,"zip":92,"country":63,"countryCode":64,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"General Hospital of Athens \"Evangelismos\"","Attica","10676",{"type":66,"coordinates":94},[95,96],23.72784,37.98376,{"lat":96,"lon":95},[99,103],{"name":100,"role":53,"phone":101,"phoneExt":49,"email":102},"Dr. Sosana Delimpasi","+30 697 720 4193","sodeli@yahoo.com",{"name":100,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":105,"status":73,"city":106,"state":106,"zip":107,"country":63,"countryCode":64,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Theageneion Cancer Hospital","Thessaloniki","54007",{"type":66,"coordinates":109},[110,111],22.93493,40.64072,{"lat":111,"lon":110},[114,118],{"name":115,"role":53,"phone":116,"phoneExt":49,"email":117},"Eirini Katoudritou","+30 697 487 2869","eirinikatodritou@gmail.com",{"name":115,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":120,"status":73,"city":121,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Emek Medical Center","Afula","1834111","Israel","IL",{"type":66,"coordinates":126},[127,128],35.2892,32.60907,{"lat":128,"lon":127},[131,135],{"name":132,"role":53,"phone":133,"phoneExt":49,"email":134},"Evgeni Chubar","972 52 7828012","Chubar_ev@clalit.org.il",{"name":132,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":137,"status":73,"city":138,"state":138,"zip":139,"country":123,"countryCode":124,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Assuta Ashdod Medical Center","Ashdod","7747629",{"type":66,"coordinates":141},[142,143],34.64966,31.79213,{"lat":143,"lon":142},[146,150],{"name":147,"role":53,"phone":148,"phoneExt":49,"email":149},"Merav Leiba","972 58 666 9161","meravlei@assuta.co.il",{"name":147,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":152,"status":73,"city":153,"state":154,"zip":155,"country":123,"countryCode":124,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Bnai-Zion Medical Center","Haifa","Haifa District","3108",{"type":66,"coordinates":157},[158,159],34.99928,32.81303,{"lat":159,"lon":158},[162,166],{"name":163,"role":53,"phone":164,"phoneExt":49,"email":165},"Tamar Tadmor","972506268114","Tamar.tadmor@b-Zion.org.il",{"name":163,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":168,"status":73,"city":153,"state":154,"zip":169,"country":123,"countryCode":124,"cosmosGeoPoint":170,"geoPoint":172,"contacts":173},"Rambam Health Care Campus","3109601",{"type":66,"coordinates":171},[158,159],{"lat":159,"lon":158},[174,178],{"name":175,"role":53,"phone":176,"phoneExt":49,"email":177},"Noa Lavi","972 50 206 1332","n_lavi@rambam.health.gov.il",{"name":175,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":180,"status":73,"city":181,"state":181,"zip":182,"country":123,"countryCode":124,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Shaare Zedek Medical Center","Jerusalem","9103102",{"type":66,"coordinates":184},[185,186],35.21633,31.76904,{"lat":186,"lon":185},[189,193],{"name":190,"role":53,"phone":191,"phoneExt":49,"email":192},"Chezi Ganzel","972-53-3342046","ganzelc@szmc.org.il",{"name":190,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":195,"status":73,"city":181,"state":181,"zip":196,"country":123,"countryCode":124,"cosmosGeoPoint":197,"geoPoint":199,"contacts":200},"Hadassah Medical Center","9112001",{"type":66,"coordinates":198},[185,186],{"lat":186,"lon":185},[201,205],{"name":202,"role":53,"phone":203,"phoneExt":49,"email":204},"Moshe Gatt","972-505172333","rmoshg@hadassah.org.il",{"name":202,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":207,"status":73,"city":208,"state":208,"zip":209,"country":123,"countryCode":124,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Rabin Medical Center (Beilinson Hospital)","Petah Tikva","49100",{"type":66,"coordinates":211},[212,213],34.88747,32.08707,{"lat":213,"lon":212},[216,220],{"name":217,"role":53,"phone":218,"phoneExt":49,"email":219},"Amos Cohen","972-50-565-1033","amosc@clalit.org.il",{"name":217,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":222,"status":73,"city":223,"state":223,"zip":224,"country":123,"countryCode":124,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"The Chaim Sheba Medical Center at Tel HaShomer","Ramat Gan","52621",{"type":66,"coordinates":226},[227,228],34.81065,32.08227,{"lat":228,"lon":227},[231,235],{"name":232,"role":53,"phone":233,"phoneExt":49,"email":234},"Hila Magen","972 50 406 5432","hila.magen@sheba.health.gov.il",{"name":232,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":237,"status":73,"city":238,"state":238,"zip":239,"country":123,"countryCode":124,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Tel Aviv Sourasky Medical Center","Tel Aviv","64239",{"type":66,"coordinates":241},[242,243],34.78057,32.08088,{"lat":243,"lon":242},[246,250],{"name":247,"role":53,"phone":248,"phoneExt":49,"email":249},"Yael Cohen","972 52 662 2575","yaelcoh@tlvmc.gov.il",{"name":247,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":252,"status":73,"city":253,"state":49,"zip":254,"country":123,"countryCode":124,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Barzilai Medical Center","Ashkelon","7830604",{"type":66,"coordinates":256},[257,258],34.57149,31.66926,{"lat":258,"lon":257},[261,263,266],{"name":262,"role":53,"phone":49,"phoneExt":49,"email":49},"Anatoly Nemets, MD",{"name":49,"role":53,"phone":264,"phoneExt":49,"email":265},"972 8 6745796","anatolyn@bmc.gov.il",{"name":262,"role":88,"phone":49,"phoneExt":49,"email":49},{"facility":268,"status":269,"city":270,"state":49,"zip":49,"country":123,"countryCode":124,"cosmosGeoPoint":271,"geoPoint":275,"contacts":49},"Soroka University Medical Center","ACTIVE_NOT_RECRUITING","Beersheba",{"type":66,"coordinates":272},[273,274],34.7913,31.25181,{"lat":274,"lon":273},{"facility":277,"status":59,"city":278,"state":49,"zip":279,"country":123,"countryCode":124,"cosmosGeoPoint":280,"geoPoint":284,"contacts":49},"Meir Medical Center","Kfar Saba","4428164",{"type":66,"coordinates":281},[282,283],34.90694,32.175,{"lat":283,"lon":282},{"type":286,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100394316","phase-2-a-study-of-selinexor-seli--low-dose-dexamethasone-ldd-in-penta-refractory-multiple-myeloma-mm-seli-and-bortezomib--ldd-in-triple-class-refractory-mm-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":297,"type":298},127,"ESTIMATED","INTERVENTIONAL",[301],"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.",[304],"Multiple Myeloma, Refractory",[306,31,307,308,35],"Multiple Myeloma","Penta-refractory Multiple Myeloma","Triple-class Refractory Multiple Myeloma","2026-01-30",{"date":311,"type":312},"2026-02-02","ACTUAL",{"date":314,"type":312},"2020-07-01",{"date":316,"type":298},"2028-01",{"name":5,"class":6},16]