[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601144":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":19,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":19,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":19,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Siltuximab","EXPERIMENTAL","Multiple myeloma patients with persistent grade 1 CRS\u002FICANS for 12 hours or grade ≥2 CRS\u002FICANS after CAR-T therapy will receive Siltuximab (11 mg\u002Fkg) immediately. If symptoms persist for another 12 hours, repeat Siltuximab and corticosteroids are allowed. If unresolved or worsened, rescue therapy with tocilizumab, corticosteroids, or other medications will be given.",[13],"Drug: Siltuximab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Siltuximab 11mg\u002Fkg",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Gang An, PhD&MD","CONTACT","86-022-23909171","angang@ihcams.ac.cn",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences","RECRUITING","Tianjin","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.17667,39.14222,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":24,"phoneExt":19,"email":25},"Gang An",{"type":43,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100601144","phase-2-a-phase-ii-study-of-siltuximab-for-crsicans-after-car-t-in-multiple-myeloma-100601144",false,"NCT07106671","A Phase II Study of Siltuximab for CRS\u002FICANs After CAR-T in Multiple Myeloma","A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity After CAR-T Treatment in Multiple Myeloma","Inclusion Criteria:\n\n1. Be informed and voluntarily sign the Informed Consent Form (ICF).\n2. Age ≥18 years old.\n3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.\n4. Developed CRS (grade ≥1) and\u002For ICANS (grade ≥1) after CAR-T treatment.\n\nExclusion Criteria:\n\n1. Creatinine clearance \\\u003C30 mL\u002Fmin.\n2. Platelet count \\\u003C75,000\u002FμL, absolute neutrophil count \\\u003C1,000\u002FμL, or hemoglobin \\\u003C60 g\u002FL at screening.\n3. ALT or AST \\>3× ULN, or bilirubin \\>2× ULN.\n4. Known severe cardiac conditions, including NYHA class III\u002FIV heart failure, uncontrolled angina, arrhythmia, or hypertension, myocardial infarction within 6 months, or other uncontrolled\u002Fsevere cardiovascular diseases, including prior cerebrovascular events with residual deficits.\n5. Severe comorbidities, including active infections, known active HBV\u002FHCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.\n6. Known intolerance to Siltuximab.\n7. Known central nervous system (CNS) involement.","ALL","18 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.",[61,62],"CRS - Cytokine Release Syndrome","Myeloma","2025-07-30",{"date":65,"type":66},"2025-08-06","ACTUAL",{"date":68,"type":55},"2025-08-10",{"date":70,"type":55},"2027-08-01",{"name":5,"class":6},1]