{"commentary":{"count":73,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":40,"podcast":22,"x_thread":11},"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\": \"NCT03761108\", \"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-MM1","nct_id":"NCT03761108","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=linker-mm1-nct03761108. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"LINKER-MM1","arms":[{"description":"Phase 1 has two parts. Part 1, consists of linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration.","label":"Linvoseltamab - Phase 1","type":"EXPERIMENTAL"},{"description":"Low Dose of linvoseltamab IV monotherapy.","label":"Linvoseltamab - Phase 2 - Cohort 1","type":"EXPERIMENTAL"},{"description":"High Dose of linvoseltamab IV monotherapy.","label":"Linvoseltamab - Phase 2 - Cohort 2","type":"EXPERIMENTAL"},{"description":"Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV linvoseltamab monotherapy.","label":"Linvoseltamab - Phase 2 - Cohort 3","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2033-06-16","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":387,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Linvoseltamab","type":"DRUG"}],"last_update":"2026-04-20","lead_sponsor":"Regeneron Pharmaceuticals","official_title":"Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2033-03-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period","timeFrame":"Up to 28 days"},{"measure":"Incidence and severity of treatment-emergent adverse events (TEAEs)","timeFrame":"Up to 5 years"},{"measure":"Incidence and severity of adverse events of special interest (AESI)","timeFrame":"Up to 5 years"},{"measure":"Assessment of the pharmacokinetics (PK) of linvoseltamab","timeFrame":"Up to 5 years"},{"measure":"Concentrations of linvoseltamab in serum over time","timeFrame":"Up to 5 years"},{"measure":"Objective response rate (ORR) as determined by an Independent Review Committee (IRC)","timeFrame":"Up to 5 years"},{"measure":"Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab","timeFrame":"Up to 5 years"},{"measure":"ORR of IV linvoseltamab as assessed by investigator","timeFrame":"Up to 5 years"}],"references":[{"citation":"Hoffman JE, Bumma N, Richter J, Dhodapkar MV, Lee HC, Suvannasankha A, Zonder JA, Maly JJ, Shah MR, Baz R, Inocencio TJ, DeVeaux M, Ivanescu C, Rodriguez Lorenc K, Kroog GS, Knorr K, Chi L, Harnett J, Ma Q, Jagannath S. Health-related quality of life with linvoseltamab treatment for relapsed/refractory multiple myeloma in LINKER-MM1. Blood Neoplasia. 2026 Mar 27;3(3):100225. doi: 10.1016/j.bneo.2026.100225. eCollection 2026 Aug.","pmid":"42564571","type":"DERIVED"},{"citation":"Lowy JA, Rogers MF, Avigan ZM, Flores MS, Samuel M, Rattu MA, Richter J. Linvoseltamab, a BCMA-directed CD3 T-cell engager for multiple myeloma: a patient-centric option via a response-adapted dosing regimen. Expert Rev Hematol. 2026 Apr;19(4):361-372. doi: 10.1080/17474086.2026.2634283. Epub 2026 Mar 4.","pmid":"41708325","type":"DERIVED"},{"citation":"Lee HC, Zonder JA, Dhodapkar MV, Jagannath S, Hoffman JE, Suvannasankha A, Shah MR, Lentzsch S, Baz R, Maly JJ, Namburi S, Pianko MJ, Ye JC, Wu KL, Silbermann R, Min CK, Vekemans MC, Munder M, Byun JM, Martinez-Lopez J, DeVeaux M, Roccia T, Chokshi D, Seraphin M, Knorr K, Boyapati A, Hazra A, Rodriguez Lorenc K, Kroog GS, Bumma N, Richter J. Linvoseltamab in Patients With Relapsed/Refractory Multiple Myeloma in the LINKER-MM1 Study: Longer Follow-Up and Subgroup Analyses. Clin Lymphoma Myeloma Leuk. 2026 Feb;26(2):e201-e212.e8. doi: 10.1016/j.clml.2025.11.004. Epub 2025 Nov 12.","pmid":"41387038","type":"DERIVED"},{"citation":"Bumma N, Richter J, Jagannath S, Lee HC, Hoffman JE, Suvannasankha A, Zonder JA, Shah MR, Lentzsch S, Baz R, Maly JJ, Namburi S, Pianko MJ, Ye JC, Wu KL, Silbermann R, Min CK, Vekemans MC, Munder M, Byun JM, Martinez-Lopez J, Cassady K, DeVeaux M, Chokshi D, Boyapati A, Hazra A, Yancopoulos GD, Sirulnik LA, Rodriguez Lorenc K, Kroog GS, Houvras Y, Dhodapkar MV. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2024 Aug 1;42(22):2702-2712. doi: 10.1200/JCO.24.01008. Epub 2024 Jun 16.","pmid":"38879802","type":"DERIVED"}],"start_date":{"date":"2019-01-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03761108"},"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-mm1-nct03761108"}