[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603568":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":39,"locations":45,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS32015","EXPERIMENTAL","Participants will receive teclistamab monotherapy.",[13],"Drug: QLS32015",{"label":15,"type":10,"description":16,"interventionNames":17},"Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)","Participants will receive either Pd or Sd based on principal investigator's choice.",[18,19,20],"Drug: Pomalidomide","Drug: Selinexor","Drug: Dexamethasone",[22,27,31,35],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","QLS32015 will be administered subcutaneously.",[9],null,{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Pomalidomide","Pomalidomide will be administered orally.",[15],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Selinexor","Selinexor will be administered orally.",[15],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"Dexamethasone","Dexamethasone will be administered orally",[15],[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Gang An, Professor","CONTACT","008613502181109","angang@ihcams.ac.cn",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"National Clinical Research Center for Blood Diseases","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":54,"coordinates":55},"Point",[56,57],117.17667,39.14222,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":62,"phoneExt":26,"email":63},"Qirou Wang","86 022 23608025","ec@ihcams.ac.cn",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100603568","phase-3-a-study-comparing-qls32015-monotherapy-versus-pomalidomide-dexamethasone-pd-or-selinexor-dexamethasone-sd-in-participants-with-relapsed-or-refractory-multiple-myeloma-100603568",false,"NCT07138209","A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥18 years old, regardless of gender.\n* Subjects should be willing and able to comply with the study schedule and protocols.\n* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 0.5 g\u002FdL; OR Urine M-protein greater than or equal to 200 mg\u002F24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg\u002FdL provided the serum FLC ratio is abnormal.\n* Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the ingredients of this product.\n* Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.\n* Has any active severe mental illness, medical illness, or other symptoms\u002Fconditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.\n* Disease is considered refractory to pomalidomide and selinexor.","ALL","18 Years",{"count":76,"type":77},228,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd\u002FSd for the treatment of relapsed or refractory multiple myeloma.",[83],"Relapsed or Refractory Multiple Myeloma","2026-05-20",{"date":86,"type":87},"2026-05-22","ACTUAL",{"date":89,"type":87},"2025-11-07",{"date":91,"type":77},"2029-12",{"name":5,"class":6},1]