{"preliminary_commentary":{"by_channel":{"x_thread":23,"youtube":7,"podcast":6,"bluesky_thread":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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03742297\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["daratumumab","KRd"],["KRd"]],"indication":"older fit newly diagnosed multiple myeloma","name":"GEM2017FIT","nct_id":"NCT03742297","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gem2017fit-nct03742297. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Bortezomib-melfalán-prednisone. Melfalán: 9mg/m2D1-4. Prednisone: 60mg/m2D1-4. Bortezomib: 1.3mg/m2 One 6 week cycleD1, 4, 8, 11, 22, 25, 29 and 32; followed by eight4-week cycleD1, 8, 15 and 22 Lenalidomida-dexametasona at low dose","label":"VMP x 9 + Lenalidomida-dexamethasone x 9","type":"ACTIVE_COMPARATOR"},{"description":"carfilzomib: 1 st cycle: 20mg/m2 day 1 and 36 mg/m2 days 2, 8, 9 \\& 15, 16. 2nd cycle: 36 mg/m2 days 1, 2, 8, 9 \\& 15, 16. Cycles 3-18: 56 mg/m2 days 1, 8 \\& 15.Lenalidomida: 25 mg, d1-21 Dexamethasone : 40 mg, d1, 8, 15, 2218 28-day cycle","label":"Carfilzomib-lenalidomida-dexamethasone regimen","type":"EXPERIMENTAL"},{"description":"Carfilzomib: 1 st cycle: 20mg/m2 day 1 and 36 mg/m2 days 2, 8, 9 \\& 15, 16. 2nd cycle: 36 mg/m2 days 1, 2, 8, 9 \\& 15, 16. Cycles 3-18: 56 mg/m2 days 1, 8 \\& 15. Lenalidomida: 25 mg, d1-21 Dexamethasone: 40 mg, d1, 8, 15, 22. Daratumumab 1800mg SC Days 1, 8, 15, 22 of cycles 1-2; Days 1 and 15 of cycles 3 and 4; Day 1 of cycles 5 to 18","label":"Carfilzomib-lenalidomida-dexamethason with daratumumab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2031-01","type":"ESTIMATED"},"conditions":["Newly Diagnosed Multiple Myeloma"],"enrollment":{"count":462,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Lenalidomide.","otherNames":[],"type":"DRUG"},{"name":"Carfilzomib","otherNames":[],"type":"DRUG"},{"name":"Bortezomib","otherNames":[],"type":"DRUG"},{"name":"Daratumumab","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Melphalan","otherNames":[],"type":"DRUG"}],"last_update":"2022-09-14","lead_sponsor":"PETHEMA Foundation","official_title":"Induction Therapy With Bortezomib-melphalan and Prednisone (VMP) Followed by Lenalidomide and Dexamethasone (Rd) Versus Carfilzomib, Lenalidomide and Dexamethasone (KRd) Plus/Minus Daratumumab, 18 Cycles, Followed by Consolidation and Maintenance Therapy With Lenalidomide and Daratumumab: Phase III, Multicenter, Randomized Trial for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-07","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Efficacy in terms of numbers of compleat responses","timeFrame":"18 months"}],"references":[{"citation":"Mateos MV, Paiva B, Cedena MT, Puig N, Sureda-Balari AM, de la Calle VG, Oriol A, Ocio EM, Rosinol L, Montes YG, Bargay J, Garcia MEG, Lakhwani S, Payer AR, Suarez-Cabrera A, Blanchard MJ, Garzon S, Montero FC, Cabanas V, de Oteyza JP, Gironella M, Martinez-Lopez J, Casasus AIT, Delgado-Beltran MP, Prieto E, Lahuerta JJ, Blade J, San-Miguel J. Induction therapy with bortezomib, melphalan, and prednisone followed by lenalidomide and dexamethasone versus carfilzomib, lenalidomide, and dexamethasone with or without daratumumab in older, fit patients with newly diagnosed multiple myeloma (GEM-2017FIT): a phase 3, open-label, multicentre, randomised clinical trial. Lancet Haematol. 2025 Aug;12(8):e588-e598. doi: 10.1016/S2352-3026(25)00143-7.","pmid":"40769684","type":"DERIVED"}],"start_date":{"date":"2018-10-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years","url":"https://clinicaltrials.gov/study/NCT03742297"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/gem2017fit-nct03742297"}