[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07393282":3,"trial-entities:NCT07393282":153,"trial-summary:NCT07393282":158},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":51,"secondary_outcomes":57,"sex":113,"minimum_age":114,"maximum_age":17,"healthy_volunteers":115,"eligibility_criteria":116,"std_ages":120,"locations":123,"central_contacts":141,"overall_officials":147,"references":151,"see_also_links":152},"NCT07393282","R5458-HM-24145","A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)","A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma","RECRUITING","2033-07-27","2026-07","2026-07-08","2026-05-21","Regeneron Pharmaceuticals","INDUSTRY",true,"This study is researching an experimental drug called linvoseltamab (also called \"study drug\") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.\n\nThe aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",null,[19],"High Risk Smoldering Multiple Myeloma (HR-SMM)",[21,22,23,24,25,26,27,28,29],"Linvoseltamab","Multiple Myeloma (MM)","B Cell Maturation Antigen (BCMA)","Bispecific antibody","Smoldering Multiple Myeloma (SMM)","Smoldering Myeloma","HR-SMM","Linozyfic","Darzalex","INTERVENTIONAL","TREATMENT",[33],"PHASE3",{"count":35,"type":36},270,"ESTIMATED",[38,45],{"type":39,"name":21,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Administered per the protocol",[21],[43,44],"REGN5458","Lynozyfic™",{"type":39,"name":46,"description":40,"armGroupLabels":47,"otherNames":48},"Daratumumab",[46],[49,50],"Darzalex Faspro®","Darzalex®",[52,55],{"measure":53,"timeFrame":54},"Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria","Up to 5 years",{"measure":56,"timeFrame":54},"Biochemical PFS per IMWG criteria",[58,61,64,66,68,70,72,74,76,78,80,82,85,87,89,91,94,96,99,102,105,107,109,111],{"measure":59,"timeFrame":60},"Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria","Up to 3 years",{"measure":62,"timeFrame":63},"Time to death","Up to 9 years",{"measure":65,"timeFrame":60},"Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria",{"measure":67,"timeFrame":60},"Best Overall Response (BOR) per IMWG criteria",{"measure":69,"timeFrame":60},"Achievement of MRD-negativity",{"measure":71,"timeFrame":60},"Sustained MRD-negativity",{"measure":73,"timeFrame":60},"Duration of MRD-negative CR",{"measure":75,"timeFrame":54},"Duration Of Response (DOR) per IMWG criteria",{"measure":77,"timeFrame":60},"Occurrence of Treatment-Emergent Adverse Events (TEAEs)",{"measure":79,"timeFrame":60},"Severity of TEAEs",{"measure":81,"timeFrame":60},"Occurrence of Serious Adverse Events (SAEs)",{"measure":83,"description":84,"timeFrame":54},"Change from baseline score in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Global Health Status (GHS)\u002FQuality of Life (QoL) scale","The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported QoL using 1 GHS\u002FQoL scale, 5 functioning scales (physical, role, emotional, cognitive and social) and 9 symptom scales \u002F items (fatigue, nausea\u002Fvomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer.\n\nFor the functioning scales and global health status \u002F QoL, scores range from 1 = \"very poor\" to 5 = \"excellent\" with higher scores indicating better functioning and positive changes from baseline indicate improvement.",{"measure":86,"timeFrame":54},"Change from baseline score in EORTC QLQ-C30 physical functioning scale",{"measure":88,"timeFrame":54},"Change from baseline score in EORTC QLQ-C30 role functioning scale",{"measure":90,"timeFrame":54},"Change from baseline score in EORTC QLQ-C30 emotional functioning scale",{"measure":92,"description":93,"timeFrame":54},"Change from baseline score in EORTC QLQ-C30 pain scale","The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported QoL using 1 GHS\u002FQoL scale, 5 functioning scales (physical, role, emotional, cognitive and social) and 9 symptom scales \u002F items (fatigue, nausea\u002Fvomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer.\n\nFor the 9 symptom scales, scores range from 1 = \"not at all\" to 9 = \"very much\" higher scores indicate higher symptom burden and negative changes from baseline indicate improvement.",{"measure":95,"timeFrame":54},"Change from baseline score in EORTC QLQ-C30 fatigue scale",{"measure":97,"description":98,"timeFrame":54},"Change from baseline score in EORTC IL478 future perspectives scale","EORTC IL478 corresponds to the EORTC QLQ-Multiple Myeloma Module 20 (MY20) future Perspective Scale. This is a is a self-administered instrument to assess QoL in persons with MM.\n\nFor the future perspective 3 items are analyzed.\n\nA high score for an item represents a high level of symptomatic problem.",{"measure":100,"description":101,"timeFrame":54},"Change from baseline score in EuroQoL-5 Dimensions 5-Level Questionnaire Visual Analogue Scale (EQ-5D-5L VAS )","The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression. Each dimension has 5 levels: \"no problems\", \"slight problems\", \"moderate problems\", \"severe problems\" and \"extreme problems\". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled \"Best imaginable health state\" and \"Worst imaginable health state\".",{"measure":103,"description":104,"timeFrame":54},"Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5) responses","FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item \"I am bothered by side effects of treatment\" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).",{"measure":106,"timeFrame":54},"Change from baseline in FACIT- Item GP5 score",{"measure":108,"timeFrame":54},"Concentrations of linvoseltamab in serum",{"measure":110,"timeFrame":54},"Occurrence of Anti-Drug Antibodies (ADAs) to linvoseltamab in serum",{"measure":112,"timeFrame":54},"Magnitude of ADA to linvoseltamab in serum","ALL","18 Years",false,{"inclusion":117,"exclusion":118,"raw_text":119},[],[],"Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status score ≤1\n2. SMM diagnosis per IMWG criteria as defined in the protocol\n3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol\n2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma\n3. History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder\n4. History of a seizure within the 12 months of randomization\n5. Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",[121,122],"ADULT","OLDER_ADULT",[124,133],{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":129,"geoPoint":130},"Emory University - Winship Cancer Institute","Atlanta","Georgia","30322","United States",{"lat":131,"lon":132},33.749,-84.38798,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":129,"geoPoint":138},"Dana Farber \u002F Harvard Cancer Center","Boston","Massachusetts","02215",{"lat":139,"lon":140},42.35843,-71.05977,[142],{"name":143,"role":144,"phone":145,"email":146},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[148],{"name":149,"affiliation":13,"role":150},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":154,"biomarkers":156},[155],"Smoldering Multiple Myeloma",[157],"Tumor Necrosis Factor Receptor Superfamily Member 17",{"nct_id":4,"found":115,"summary":17,"prompt_version":17}]