[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650280":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":30,"locations":36,"responsibleParty":145,"collaborators":10,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":10,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":10,"enrollmentInfo":156,"targetDuration":10,"studyType":159,"phases":10,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":171,"whyStopped":10,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Fondazione EMN Italy Onlus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational: MM Patient Cohort",null,"This cohort includes transplant-eligible patients with newly diagnosed multiple myeloma (NDMM) who have completed first-line anti-CD38-based quadruplet induction therapy and autologous stem cell transplantation (ASCT).",[13,14,15],"Diagnostic Test: DW-MRI (MY-RADS\u002FRAC score)","Diagnostic Test: Fat Fraction (rFF%)","Other: Clinical Data Collection",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DIAGNOSTIC_TEST","DW-MRI (MY-RADS\u002FRAC score)","Collection and analysis of Diffusion-Weighted Whole-body MRI data performed post-ASCT. The radiological response is evaluated using the Response Assessment Category (RAC) score (1 to 5) according to MY-RADS criteria.",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Fat Fraction (rFF%)","Quantitative assessment of the relative Fat Fraction (percentage of fat within skeletal regions) measured on residual focal lesions after transplantation to identify functional high-risk (FHR) patients.",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Clinical Data Collection","Retrospective and prospective collection of clinical outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Minimal Residual Disease (MRD) status from medical records.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"FONDAZIONE EMN ITALY ETS FONDAZIONE EMN ITALY ETS","CONTACT","+390110243236","clinicaltrialoffice@emnitaly.org",[37,48,56,68,80,92,104,113,125,137],{"facility":38,"status":10,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"IRCCS Istituto Tumori \"G. Paolo II - U.O.C. Ematologia e Terapia Cellulare","Bari","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],16.86982,41.12066,{"lat":46,"lon":45},{"facility":49,"status":10,"city":50,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":51,"geoPoint":55,"contacts":10},"A.O.U. di Bologna - Policlinico S. Orsola Malpighi","Bologna",{"type":43,"coordinates":52},[53,54],11.33875,44.49381,{"lat":54,"lon":53},{"facility":57,"status":10,"city":58,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"A.O. 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Ospedale S. Raffaele","Milan",{"type":43,"coordinates":96},[97,98],12.59836,42.78235,{"lat":98,"lon":97},[101],{"name":102,"role":33,"phone":10,"phoneExt":10,"email":103},"Francesca Farina","farina.francesca@hsr.it",{"facility":105,"status":10,"city":94,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Ospedale Niguarda",{"type":43,"coordinates":107},[97,98],{"lat":98,"lon":97},[110],{"name":111,"role":33,"phone":10,"phoneExt":10,"email":112},"Maria Luisa Pioltelli","MariaLuisa.Pioltelli@ospedaleniguarda.it",{"facility":114,"status":10,"city":115,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"A.O.U. Maggiore della Carità","Novara",{"type":43,"coordinates":117},[118,119],8.62118,45.44694,{"lat":119,"lon":118},[122],{"name":123,"role":33,"phone":10,"phoneExt":10,"email":124},"Paola Boggione","paola.boggione@uniupo.it",{"facility":126,"status":10,"city":127,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Policlinico S. Matteo Fondazione IRCCS","Pavia",{"type":43,"coordinates":129},[130,131],9.15917,45.19205,{"lat":131,"lon":130},[134],{"name":135,"role":33,"phone":10,"phoneExt":10,"email":136},"Silvia Mangiacavalli","silvia.mangiacavalli@gmail.com",{"facility":138,"status":10,"city":139,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":140,"geoPoint":144,"contacts":10},"ASL Roma 1","Rome",{"type":43,"coordinates":141},[142,143],12.51133,41.89193,{"lat":143,"lon":142},{"type":146,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100650280","validating-dw-mri-and-fat-fraction-in-multiple-myeloma-post-asct-the-rac-fat-study-100650280",false,"NCT07746232","Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study\"","Multicenter Observational Study for the Validation of the Predictive Role of Diffusion-Weighted Whole-body MRI (DW-MRI) Imaging Response According to MY-RADS Criteria (RAC Score) and Fat Fraction (rFF%) After Autologous Stem Cell Transplantation in Multiple Myeloma Patients Treated With First-Line Anti-CD38-Based Therapy (RAC-FAT Study)","Inclusion criteria:\n\n* Newly diagnosed MM participants eligible for ASCT, treated with anti-CD38-based quadruplet induction therapy and ASCT, with post-ASCT\u002Fpremaintenance DW-MRI available (in tandem ASCT, DW-MRI after second ASCT will be considered).\n* Age ≥18 years.\n* Participant must sign an informed consent form (ICF) that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.\n\nExclusion Criteria:\n\n\\- Absence of post-ASCT\u002Fpre-maintenance DW-MRI.","ALL","18 Years",{"count":157,"type":158},92,"ESTIMATED","OBSERVATIONAL","This is a multicenter, observational, retrospective-prospective study designed to validate the predictive role of advanced imaging in patients with newly diagnosed multiple myeloma (NDMM). The main purpose of this study is to estimate the prevalence of radiological response categories (Response Assessment Category, RAC score) and evaluate the predictive value of relative Fat Fraction (rFF%) using Diffusion-Weighted Whole-Body Magnetic Resonance Imaging (DW-MRI) in patients who have undergone autologous stem cell transplantation (ASCT) after receiving first-line anti-CD38-based quadruplet induction therapy.",[162],"Multiple Myeloma (MM)",[164,165,166,167,168,23,169,170],"Newly diagnosed multiple myeloma (NDMM)","Transplant-eligible (TE)","Diffusion-weighted whole-body MRI (DW-MRI)","MY-RADS criteria","Response Assessment Category (RAC score)","Autologous Stem Cell Transplantation (ASCT)","Anti-CD38-based therapy","NOT_YET_RECRUITING","2026-07-30",{"date":174,"type":175},"2026-08-04","ACTUAL",{"date":177,"type":158},"2026-08",{"date":179,"type":158},"2030-08",{"name":5,"class":6},10]