{"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":"MUKnineb","nct_id":"NCT03188172","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=muknineb-nct03188172. 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":"MUKnineb","arms":[{"description":"Induction:\n\nCyclophosphamide 500mg, days 1, 8 Bortezomib 1.3mg/m2, days 1, 4, 8, 11 Lenalidomide 25mg, days 1-14 Daratumumab 16mg/kg, days 1, 8, 15 (cycles 1\\& 2), day 1 only from cycle 3 Dexamethasone 20-40mg, days 1, 4, 8, 11\n\nASCT stem cell harvest:\n\nwith Bortezomib 1.3mg/m2, (12 hours post melphalan) Bortezomib 1.3mg/m2, day +5, +14, weekly\n\nConsolidation part 1:\n\nBortezomib 1.3mg/m2 days 1, 8, 15, 22 Lenalidomide 25mg days 1-21 Daratumumab 16mg/kg day 1 Dexamethasone 20-40mg days 1, 8, 15, 22\n\nConsolidation part 2:\n\nBortezomib 1.3mg/m2 days 1, 8, 15 Lenalidomide 25mg days 1-21 Daratumumab 16mg/kg day 1\n\nMaintenance:\n\nLenalidomide 10mg days 1-21 Daratumumab 16mg/kg day 1","label":"Trial Treatment","type":"EXPERIMENTAL"}],"collaborators":["Myeloma UK","Celgene","Janssen, LP"],"completion_date":{"date":"2026-05-31","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":95,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Bortezomib","otherNames":["Velcade"],"type":"DRUG"},{"name":"Lenalidomide","otherNames":["Revlamid"],"type":"DRUG"},{"name":"Daratumumab","otherNames":["Daralex"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Melphalan","otherNames":[],"type":"DRUG"},{"name":"Filgrastim","otherNames":[],"type":"DRUG"}],"last_update":"2024-05-14","lead_sponsor":"University of Leeds","official_title":"MUK Nine b: OPTIMUM. A Phase II Study Evaluating Optimised Combination of Biological Therapy in Newly Diagnosed High Risk Multiple Myeloma and Plasma Cell Leukaemia.","overall_status":"UNKNOWN","phases":["PHASE2"],"primary_completion_date":{"date":"2025-10-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression free survival","timeFrame":"At 18 months post registration"}],"references":[{"citation":"Kaiser MF, Phillip RH, Brown SR, Holroyd A, Ferris E, de Tute RM, Roberts S, Clayton L, Bowles K, Garg M, Lokare A, Messiou C, Houlston RS, Jackson G, Cook G, Owen RG, Drayson MT, Pratt G, Hall A, Jenner MW. Induction and extended consolidation with daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone in patients with high-risk multiple myeloma (OPTIMUM/MUKnine): 5-year follow-up of a multicentre, externally controlled, phase 2 trial. Lancet Oncol. 2026 Sep 7:S1470-2045(26)00286-X. doi: 10.1016/S1470-2045(26)00286-X. Online ahead of print.","pmid":"42705255","type":"DERIVED"},{"citation":"Keaveney S, Dragan A, Rata M, Blackledge M, Scurr E, Winfield JM, Shur J, Koh DM, Porta N, Candito A, King A, Rennie W, Gaba S, Suresh P, Malcolm P, Davis A, Nilak A, Shah A, Gandhi S, Albrizio M, Drury A, Pratt G, Cook G, Roberts S, Jenner M, Brown S, Kaiser M, Messiou C. Image quality in whole-body MRI using the MY-RADS protocol in a prospective multi-centre multiple myeloma study. Insights Imaging. 2023 Oct 15;14(1):170. doi: 10.1186/s13244-023-01498-3.","pmid":"37840055","type":"DERIVED"},{"citation":"Kaiser MF, Hall A, Walker K, Sherborne A, De Tute RM, Newnham N, Roberts S, Ingleson E, Bowles K, Garg M, Lokare A, Messiou C, Houlston RS, Jackson G, Cook G, Pratt G, Owen RG, Drayson MT, Brown SR, Jenner MW. Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, and Dexamethasone as Induction and Extended Consolidation Improves Outcome in Ultra-High-Risk Multiple Myeloma. J Clin Oncol. 2023 Aug 10;41(23):3945-3955. doi: 10.1200/JCO.22.02567. Epub 2023 Jun 14.","pmid":"37315268","type":"DERIVED"},{"citation":"Rata M, Blackledge M, Scurr E, Winfield J, Koh DM, Dragan A, Candito A, King A, Rennie W, Gaba S, Suresh P, Malcolm P, Davis A, Nilak A, Shah A, Gandhi S, Albrizio M, Drury A, Roberts S, Jenner M, Brown S, Kaiser M, Messiou C. Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma. Insights Imaging. 2022 Jul 28;13(1):123. doi: 10.1186/s13244-022-01253-0.","pmid":"35900614","type":"DERIVED"},{"citation":"Oliva S, Kaiser MF. Is it time to tailor treatment on the basis of minimal residual disease in multiple myeloma? Lancet Haematol. 2021 Dec;8(12):e876-e877. doi: 10.1016/S2352-3026(21)00341-0. No abstract available.","pmid":"34826409","type":"DERIVED"},{"citation":"Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available.","pmid":"33357481","type":"DERIVED"}],"start_date":{"date":"2017-09-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"MUK Nine b: OPTIMUM Treatment Protocol","url":"https://clinicaltrials.gov/study/NCT03188172"},"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/muknineb-nct03188172"}