{"commentary":{"count":59,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":29,"x_thread":18,"podcast":12},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05405166\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"IRAKLIA","nct_id":"NCT05405166","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=iraklia-nct05405166. The price is fixed at order. We build the report after 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: 41+ commentary sources"},"registry":{"acronym":"IRAKLIA","arms":[{"description":"Isatuximab dose will administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.","label":"Isatuximab Subcutaneous (SC)","type":"EXPERIMENTAL"},{"description":"Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.","label":"Isatuximab Intravenous (IV)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-10-22","type":"ESTIMATED"},"conditions":["Plasma Cell Myeloma Recurrent"],"enrollment":{"count":531,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Isatuximab IV","type":"DRUG"},{"name":"Isatuximab SC","type":"DRUG"},{"name":"Dexamethasone","type":"DRUG"},{"name":"Pomalidomide","type":"DRUG"},{"name":"Dexamethasone","type":"DRUG"},{"name":"Montelukast","type":"DRUG"},{"name":"Paracetamol / Acetaminophen","type":"DRUG"},{"name":"Diphenhydramine","type":"DRUG"},{"name":"Methylprednisolone","type":"DRUG"}],"last_update":"2026-09-02","lead_sponsor":"Sanofi","official_title":"A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-11-06","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Response Rate (ORR)","timeFrame":"From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months"},{"measure":"Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State","timeFrame":"Pre-dose at Cycle 6 Day 1"}],"references":[{"citation":"Ailawadhi S, Spicka I, Spencer A, Lu J, Oriol A, Ling S, Schjesvold F, Berkovits A, Hus M, Li C, Dimopoulos MA, Rajnics P, Besisik SK, Hungria V, Custidiano MDR, Parmar G, Leleu X, Li F, Cerchione C, Gomez C, Ishida T, Mateos MV, Buck TT, LeBlanc R, Minarik J, Goldschmidt H, Zhang R, Semiond D, Suzan F, Stefanova-Urena M, Koch V, Moreau P. Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study. J Clin Oncol. 2025 Aug;43(22):2527-2537. doi: 10.1200/JCO-25-00744. Epub 2025 Jun 3.","pmid":"40459178","type":"DERIVED"}],"start_date":{"date":"2022-06-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM","url":"https://clinicaltrials.gov/study/NCT05405166"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/iraklia-nct05405166"}