{"preliminary_commentary":{"by_channel":{"x_thread":5,"youtube":1,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["belantamab mafodotin","lenalidomide","dexamethasone"]],"indication":"transplant-ineligible newly diagnosed multiple myeloma","name":"BelaRd","nct_id":"NCT04808037","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=belard-nct04808037. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"BelaRd","arms":[{"description":"12 patients are anticipated to receive Belantamab Mafodotin 2.5 Q8W = 2.5 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone","label":"Cohort 1, First Part","type":"EXPERIMENTAL"},{"description":"12 patients are anticipated to receive Belantamab Mafodotin 1.9 Q8W = 1.9 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone","label":"Cohort 2, First Part","type":"EXPERIMENTAL"},{"description":"12 patients are anticipated to receive Belantamab Mafodotin 1.4 Q8W = 1.4 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone","label":"Cohort 3, First Part","type":"EXPERIMENTAL"},{"description":"15 patients are anticipated to receive Belantamab Mafodotin in the Recommended Phase 2 Dose, in combination with Lenalidomide and Dexamethasone.\n\nIn this Arm the ocular toxicity will be graded according to the Dose Modification Guidelines for Corneal-Related Adverse Events Associated with belantamab mafodotin","label":"Group A, Second Part","type":"EXPERIMENTAL"},{"description":"15 patients are anticipated to receive Belantamab Mafodotin in the Recommended Phase 2 Dose, in combination with Lenalidomide and Dexamethasone.\n\nIn this Arm the ocular toxicity will be graded according to the Dose modification guidance based on visual acuity","label":"Group B, Second Part","type":"EXPERIMENTAL"}],"collaborators":["GlaxoSmithKline"],"completion_date":{"date":"2028-11-08","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":66,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Belantamab mafodotin","otherNames":["Blenrep"],"type":"DRUG"}],"last_update":"2023-10-24","lead_sponsor":"Hellenic Society of Hematology","official_title":"A Phase 1/2 Study of Belantamab Mafodotin in Combination With Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-09-08","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of participants with dose-limiting toxicities (DLTs) in each of the cohorts 1-3","timeFrame":"Five (5) years after last participant randomization"},{"measure":"Overall Response rate as per IMWG by Investigator Assessment, defined as the percentage of participants with a confirmed PR, VGPR, CR or sCR","timeFrame":"Five (5) years after last participant randomization"},{"measure":"Number of participants with adverse events (AEs) and serious adverse events (SAEs) in each of the cohorts 1-3","timeFrame":"Five (5) years after last participant randomization"},{"measure":"Number of participants with adverse events (AEs) and serious adverse events (SAEs) in patients receiving the Recommended Phase 2 Dose","timeFrame":"Five (5) years after last participant randomization"}],"references":[{"citation":"Terpos E, Gavriatopoulou M, Ntanasis-Stathopoulos I, Malandrakis P, Fotiou D, Kanellias N, Migkou M, Theodorakakou F, Spiliopoulou V, Solia E, Eleutherakis-Papaiakovou E, Psarros G, Kastritis E, Dimopoulos MA. Belantamab mafodotin, lenalidomide, and dexamethasone for intermediate-fit and frail patients with newly diagnosed myeloma. Blood. 2026 Apr 2;147(14):1574-1583. doi: 10.1182/blood.2025031629.","pmid":"41346230","type":"DERIVED"},{"citation":"Gavriatopoulou M, Ntanasis-Stathopoulos I, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Spiliopoulou V, Kanellias N, Eleutherakis-Papaiakovou E, Roussou M, Psarros G, Kastritis E, Dimopoulos MA, Terpos E. Belantamab mafodotin, lenalidomide, and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma: Analysis of belantamab mafodotin-associated ocular adverse events and their impact on daily functioning from the part 1 of a phase 1/2 study. Am J Hematol. 2024 Mar;99(3):502-504. doi: 10.1002/ajh.27219. Epub 2024 Jan 25. No abstract available.","pmid":"38270219","type":"DERIVED"}],"start_date":{"date":"2021-02-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT04808037"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/belard-nct04808037"}