{"commentary":{"count":29,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":15,"podcast":12,"x_thread":2},"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\": \"NCT05704049\", \"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":"IZALCO","nct_id":"NCT05704049","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=izalco-nct05704049. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"IZALCO","arms":[{"description":"Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.","label":"Cohort 1: manual administration","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.","label":"Part 1 Cohort 2: manual administration","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.","label":"Part 2 Cohort 3 Randomized Cohort: OBDS to manual","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.","label":"Part 2 Cohort 3 Randomized Cohort: Manual to OBDS","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.","label":"Part 3 Cohort 4 Randomized Cohort: OBDS to manual","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.","label":"Part 3 Cohort 4: Randomized Cohort: manual to OBDS","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.","label":"Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants","type":"EXPERIMENTAL"},{"description":"Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.","label":"Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-05-12","type":"ESTIMATED"},"conditions":["Relapsed/Refractory Multiple Myeloma"],"enrollment":{"count":118,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Isatuximab","type":"DRUG"},{"name":"Carfilzomib","type":"DRUG"},{"name":"Dexamethasone","type":"DRUG"},{"name":"Dexamethasone IV","type":"DRUG"},{"name":"Montelukast","type":"DRUG"},{"name":"Acetaminophen","type":"DRUG"},{"name":"Diphenhydramine","type":"DRUG"},{"name":"Methylprednisolone","type":"DRUG"}],"last_update":"2025-12-29","lead_sponsor":"Sanofi","official_title":"A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-12-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall response rate (ORR) - Cohorts 1 to 3","timeFrame":"6 months after the Last Participant In (LPI) i.e., approximately 16 months"},{"measure":"Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5","timeFrame":"Cycle 1 (28 days)"},{"measure":"Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5","timeFrame":"Cycle 1 (28 days)"}],"references":[{"citation":"Parmar G, Capra M, Seguro F, Hungria V, Dimopoulos MA, Delimpasi S, Minarik J, Spicka I, Pour L, Marques H, Esteves G, Sunami K, Yuda J, Hajek R, Mihalyova J, Soufflet C, Yu D, Benlhassan K, Koch V, Comerford E, Cordero P, Suzan F, Quach H. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025 Dec 27;16(1):16. doi: 10.1038/s41408-025-01436-0.","pmid":"41455697","type":"DERIVED"}],"start_date":{"date":"2023-04-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT05704049"},"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/izalco-nct05704049"}