{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":null,"indication":null,"name":"CHAMPION-1","nct_id":"NCT01677858","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=champion-1-nct01677858. 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":"CHAMPION 1","arms":[{"description":"In phase 1 participants were assigned to one of four sequential dose-escalating cohorts to receive 45, 56, 70 or 88 mg/m² carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.\n\nIn phase 2 participants received carfilzomib at the maximum tolerated dose (MTD) established in the Phase 1 portion of the study on days 1, 8 and 15 plus 40 mg dexamethasone IV or orally at the same schedule as used in the Phase 1 portion of the study.\n\nParticipants were treated until confirmed progressive disease, unacceptable toxicity, withdrew consent for further treatment, were lost to follow-up, died, or the sponsor closed the study.","label":"Carfilzomib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2018-10-31","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":116,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Carfilzomib","otherNames":["Krypolis"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2022-09-23","lead_sponsor":"Amgen","official_title":"A Phase 1/2 Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2016-07-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)","timeFrame":"28 days"},{"measure":"Overall Response Rate (ORR)","timeFrame":"Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks."}],"references":[{"citation":"Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.","pmid":"32108443","type":"BACKGROUND"},{"citation":"Berenson JR, Cartmell A, Bessudo A, Lyons RM, Harb W, Tzachanis D, Agajanian R, Boccia R, Coleman M, Moss RA, Rifkin RM, Patel P, Dixon S, Ou Y, Anderl J, Aggarwal S, Berdeja JG. CHAMPION-1: a phase 1/2 study of once-weekly carfilzomib and dexamethasone for relapsed or refractory multiple myeloma. Blood. 2016 Jun 30;127(26):3360-8. doi: 10.1182/blood-2015-11-683854. Epub 2016 May 12.","pmid":"27207788","type":"DERIVED"}],"start_date":{"date":"2012-07-04"},"study_type":"INTERVENTIONAL","title":"A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT01677858"},"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/champion-1-nct01677858"}