{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"LIGHTHOUSE","nct_id":"NCT04649060","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=lighthouse-nct04649060. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"LIGHTHOUSE","arms":[{"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","label":"Arm A (melflufen+dexamethasone+daratumumab)","type":"EXPERIMENTAL"},{"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","label":"Arm B (daratumumab)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-02-07","type":"ACTUAL"},"conditions":["Relapsed Multiple Myeloma","Relapsed-Refractory Multiple Myeloma"],"enrollment":{"count":54,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Melflufen","otherNames":["Melphalan Flufenamide","Pepaxto","Pepaxti"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":["Dex"],"type":"DRUG"},{"name":"Daratumumab","otherNames":["Darzalex FASPRO"],"type":"DRUG"}],"last_update":"2023-06-08","lead_sponsor":"Oncopeptides AB","official_title":"A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-02-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS)","timeFrame":"From the date of randomization until the end of study (approximately 12 months)."}],"references":[{"citation":"Pour L, Szarejko M, Bila J, Schjesvold FH, Spicka I, Maisnar V, Jurczyszyn A, Grudeva-Popova Z, Hajek R, Usenko G, Thuresson M, Norin S, Jarefors S, Bakker NA, Richardson PG, Mateos MV. Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study. Haematologica. 2024 Mar 1;109(3):895-905. doi: 10.3324/haematol.2023.283509.","pmid":"37646660","type":"DERIVED"},{"citation":"Ocio EM, Efebera YA, Hajek R, Straub J, Maisnar V, Eveillard JR, Karlin L, Mateos MV, Oriol A, Ribrag V, Richardson PG, Norin S, Obermuller J, Bakker NA, Pour L. ANCHOR: melflufen plus dexamethasone and daratumumab or bortezomib in relapsed/refractory multiple myeloma: final results of a phase I/IIa study. Haematologica. 2024 Mar 1;109(3):867-876. doi: 10.3324/haematol.2023.283490.","pmid":"37646657","type":"DERIVED"}],"start_date":{"date":"2020-12-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT04649060"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/lighthouse-nct04649060"}