[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583300":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":13,"locations":19,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":50,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":22,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8,11],{"label":9,"type":10,"description":9,"interventionNames":10},"Analysis group that based on cytogenetic profile has 1q21 aberrations.",null,{"label":12,"type":10,"description":12,"interventionNames":10},"Analysis group that based on cytogenetic profile absent for 1q21 aberration.",[14],{"name":15,"role":16,"phone":17,"phoneExt":10,"email":18},"Elena Zamagni, PI","CONTACT","+39 051 636 3 831","e.zamagni@unibo.it",[20],{"facility":21,"status":22,"city":23,"state":10,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"IRCCS Azienda Ospedaliera-Universitaria di Bologna","RECRUITING","Bologna","40138","Italy","IT",{"type":28,"coordinates":29},"Point",[30,31],11.33875,44.49381,{"lat":31,"lon":30},[34],{"name":15,"role":16,"phone":17,"phoneExt":10,"email":18},{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100583300","efficacy-of-isatuximab-based-regimens-in-relapsedrefractory-multiple-myeloma-with-1q21-100583300",false,"NCT06874530","Efficacy of Isatuximab-based Regimens in Relapsed\u002FRefractory Multiple Myeloma With 1q21+","Efficacy of Isatuximab-basedregimens in Relapsed\u002FRefractory Multiple Myeloma With 1q21+","Isa_1q21+","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Signed Informed Consent form (whenever feasible)\n* Diagnosis of RRMM prior exposed to \\>1 lines of therapies including Isatuximab-based regimens\n* Availability of FISH results, including 1q2, at diagnosis and\u002For at relapse\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":48,"type":49},30,"ESTIMATED","8 Months","OBSERVATIONAL","This is a non-interventional, national, multicentre retrospective and prospective observational study aiming at assessing the efficacy of isatuximab-based regimens in RRMM patients with 1q21+ in a real-life setting.\n\nDue to the limited information as to isatuximab's impact in real-world settings and that MM is a rare cancer, patients will be enrolled both prospectively and retrospectively from approximately 8 haematologic\u002Foncologic centers in Italy. Prospective enrollment will allow an assessment of true baseline and the beneficial treatment of isatuximab among RRMM patients with 1q21+. The inclusion of retrospectively enrolled patients previously exposed to isatuximab-based regimens (Isa-Pd and Isa-Kd) will allow for maximal data capture to evaluate isatuximab treatment as part of routine care.\n\nAll the sites participating in the study are using isatuximab-based regimens for the treatment of RRMM patients in clinical practice. According to data availability and\u002For clinical experience of the sites, data from approximately 150 patients consecutively treated in the participating centers will be collected in the present study and compared with data published in the literature.",[54],"Multiple Mieloma",[56,57,58,59],"Relapsed","Refractory","Isatuximab","1q21+","2025-03-07",{"date":62,"type":63},"2025-03-13","ACTUAL",{"date":65,"type":63},"2023-12-27",{"date":67,"type":49},"2026-01-31",{"name":5,"class":6},1]