{"commentary":{"count":26,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":16,"youtube":7,"podcast":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05828511\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"LINKER-MM4","nct_id":"NCT05828511","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=linker-mm4-nct05828511. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"LINKER-MM4","arms":[{"description":"Linvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.","label":"Phase 1 cohorts","type":"EXPERIMENTAL"},{"description":"Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.","label":"Phase 2 - transplant ineligible cohort","type":"EXPERIMENTAL"},{"description":"Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol","label":"Phase 2 - transplant eligible cohort","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2035-11-02","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":149,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Linvoseltamab","type":"DRUG"}],"last_update":"2026-05-13","lead_sponsor":"Regeneron Pharmaceuticals","official_title":"Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2035-11-02","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of Dose-Limiting Toxicities (DLTs)","timeFrame":"End of the Observation period; up to day 28"},{"measure":"Incidence of Treatment-Emergent Adverse Events (TEAEs)","timeFrame":"Post-Last Linvoseltamab Dose, up to 90 days"},{"measure":"Severity of TEAEs","timeFrame":"Post-Last Linvoseltamab Dose, up to 90 days"},{"measure":"Incidence of Adverse Events of Special Interest (AESIs)","timeFrame":"Post-Last Linvoseltamab Dose, up to 90 days"},{"measure":"Severity of AESIs","timeFrame":"Post-Last Linvoseltamab Dose, up to 90 days"},{"measure":"Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria","timeFrame":"Up to 5 years"},{"measure":"Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy","timeFrame":"Up to 5 years"},{"measure":"Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy","timeFrame":"Up to 5 years"},{"measure":"Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II","timeFrame":"Up to 5 years"},{"measure":"Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II","timeFrame":"Up to 5 years"}],"references":[],"start_date":{"date":"2023-12-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment","url":"https://clinicaltrials.gov/study/NCT05828511"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/linker-mm4-nct05828511"}