[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587814":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":34,"responsibleParty":50,"collaborators":13,"id":52,"slug":13,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":13,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":13,"enrollmentInfo":60,"targetDuration":13,"studyType":63,"phases":13,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":37,"whyStopped":13,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"SdV therapy effectiveness in terms of Progression Free Survival","to describe the effectiveness of the use of SVd therapy outside clinical trials in terms of Progression free survival after 12 months from the start of treatment","at 12 months",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_ONLY","PROSPECTIVE","This is a non-interventional, national, multicenter prospective and retrospective observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy.\n\nAll the sites participating in the study are using SVd in clinical practice. According to sample size calculation, a minimum of 159 patients is required.\n\nOverall study duration is estimated in 36 months: 24 months on enrolment and at least 12 months of observation.","this study will include patients who will start SVD treatment during the study enrolment period or who received at least one dose of the treatment according to AIFA authorization before the study inclusion date.",[20],{"name":21,"affiliation":22,"role":23},"Elena Zamagni","UOC di Ematologia Policlinico S.Orsola AOU di Bologna","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":13,"email":29},"Paola Fazi","CONTACT","0670390528","p.fazi@gimema.it",{"name":31,"role":27,"phone":32,"phoneExt":13,"email":33},"Enrico Crea","0670390514","e.crea@gimema.it",[35],{"facility":36,"status":37,"city":38,"state":13,"zip":13,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Aou Careggi - Sod Ematologia","RECRUITING","Florence","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.24626,43.77925,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":13,"phoneExt":13,"email":13},"Elisabetta Antonioli",{"type":51,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100587814",false,"NCT06933277","Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients","Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients","Inclusion Criteria:\n\n* Age equal to or greater than 18 years old at the time of SVd initiation\n* Signed informed consent (if applicable).\n* Diagnosis of symptomatic MM, as defined by the International Myeloma Working Group (IMWG) criteria.\n* Relapse after one to three lines of therapy.\n* Treatment with SVd, (i.e., having already received at least one dose) at the time the combination has entered clinical practice in Italy (AIFA authorization)\n* Prior treatment with and refractoriness to lenalidomide.\n\nExclusion Criteria:\n\n\\- Previous exposure to selinexor.","ALL","18 Years",{"count":61,"type":62},159,"ESTIMATED","OBSERVATIONAL","This is an observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy.\n\nA minimum of 159 patients is required. Overall study duration is estimated in 36 months.",[66],"Multiple Myeloma",[68,69,70],"selinexor","bortezomib","dexamethasone","2025-09-03",{"date":73,"type":74},"2025-09-10","ACTUAL",{"date":76,"type":74},"2025-08-29",{"date":78,"type":62},"2028-08",{"name":5,"class":6},1]