{"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":"NCT04504825","nct_id":"NCT04504825","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04504825. 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":null,"arms":[{"description":"CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. It is planned that all patients will continue their double-blind treatment until the last patient is randomized in the study plus 18 months. The study is divided into 2 parts, the Primary Evaluation Treatment period part and the Open-Label Extension period of Study.","label":"CAEL-101 combined with SoC plasma cell dyscrasia","type":"EXPERIMENTAL"},{"description":"Patients randomized to receive placebo will receive 0.9% normal saline in an equivalent volume to a CAEL-101 infusion (approximately 250 cc). It is planned that all patients will continue their double-blind treatment until the last patient is randomized in the study plus 18 months.","label":"Placebo combined with SoC plasma cell dyscrasia","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-10-22","type":"ESTIMATED"},"conditions":["AL Amyloidosis"],"enrollment":{"count":125,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"CAEL-101","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"OTHER"},{"name":"cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen","otherNames":[],"type":"DRUG"}],"last_update":"2026-07-02","lead_sponsor":"Alexion Pharmaceuticals, Inc.","official_title":"A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-05-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"A Hierarchical Combination of Time to All-cause Mortality and Frequency of Cardiovascular Hospitalizations (CVHs) Analyzed by Win Ratio","timeFrame":"Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-47 months after the study randomization.)"},{"measure":"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","timeFrame":"Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-47 months after the study randomization.)"}],"references":[{"citation":"Wechalekar AD, Dispenzieri A, Sanchorawala V, Kastritis E, Bhutani D, Bianchi G, Jimenez-Zepeda VH, Suzuki K, Lentzsch S, Huart A, Carpinteiro A, Swenson ES, Khan Z, Catini J, Kulkarni H, Meltzer B, Lake S, Liedtke M; CARES Investigators. Efficacy and Safety of Anselamimab in Immunoglobulin Light Chain Amyloidosis: Results From the Randomized CARES Trials. J Clin Oncol. 2026 Jul 10;44(20):1899-1910. doi: 10.1200/JCO-26-00755. Epub 2026 May 29.","pmid":"42212672","type":"DERIVED"}],"start_date":{"date":"2020-08-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)","url":"https://clinicaltrials.gov/study/NCT04504825"},"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/nct04504825"}