{"commentary":{"count":97,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":50,"podcast":30,"x_thread":17},"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\": \"NCT03275285\", \"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":"IKEMA","nct_id":"NCT03275285","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ikema-nct03275285. 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":"IKEMA","arms":[{"description":"Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth \\[po\\]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.","label":"Isatuximab + Carfilzomib + Dexamethasone (IKd)","type":"EXPERIMENTAL"},{"description":"Carfilzomib (intravenous) on day 1, 2, 8, 9, 15, 16 + dexamethasone (intravenous or po) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.","label":"Carfilzomib + Dexamethasone (Kd)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-01-03","type":"ACTUAL"},"conditions":["Plasma Cell Myeloma"],"enrollment":{"count":302,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"isatuximab SAR650984","type":"DRUG"},{"name":"carfilzomib","type":"DRUG"},{"name":"dexamethasone","type":"DRUG"}],"last_update":"2026-02-09","lead_sponsor":"Sanofi","official_title":"Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-01-14","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis","timeFrame":"From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months)"},{"measure":"Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis","timeFrame":"From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)"},{"measure":"Progression Free Survival as Determined by Independent Response Committee: Final Analysis","timeFrame":"From randomization until the final analysis data cut-off date of 14 January 2022 (the median duration of follow-up was 43.96 months)"},{"measure":"Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis","timeFrame":"From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)"}],"references":[{"citation":"Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Risse ML, Asset G, Mace S, Martin T; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.","pmid":"34097854","type":"RESULT"},{"citation":"Martin TG, Capra M, Mohty M, Suzuki K, Quach H, Cavo M, Moreau P, Dimopoulos M, Yong K, Tekle C, Foster MC, Barnes Y, Risse ML, Mikhael J. Isatuximab Plus Carfilzomib and Dexamethasone Versus Carfilzomib and Dexamethasone in Patients with Relapsed Multiple Myeloma: IKEMA Subgroup Analysis by Prior Transplantation. Transplant Cell Ther. 2023 Feb;29(2):134.e1-134.e7. doi: 10.1016/j.jtct.2022.11.005. Epub 2022 Nov 11.","pmid":"36372355","type":"RESULT"},{"citation":"Chami B, Okuda M, Moayeri M, Pirenne F, Hidaka Y, Nambiar A, Song Z, Bedel O, Zhang B, Hopke J, Deng G, Zhu C, Mace S, Chiron M, Adrian F, Fukao T, Basile FG, Martin T. Anti-CD38 monoclonal antibody interference with blood compatibility testing: Differentiating isatuximab and daratumumab via functional epitope mapping. Transfusion. 2022 Nov;62(11):2334-2348. doi: 10.1111/trf.17137. Epub 2022 Oct 14.","pmid":"36239134","type":"RESULT"},{"citation":"Yong K, Martin T, Dimopoulos MA, Mikhael J, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Casca F, Mace S, Moreau P. Plain language summary of publication of how long people with relapsed multiple myeloma lived after treatment in the IKEMA study: Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone. Future Oncol. 2026 Jun;22(15):1737-1749. doi: 10.1080/14796694.2026.2683336. Epub 2026 Jun 27.","pmid":"42363804","type":"DERIVED"},{"citation":"Yong K, Martin T, Dimopoulos MA, Mikhael J, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Casca F, Mace S, Risse ML, Moreau P. Isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple myeloma (IKEMA): overall survival analysis of a phase 3, randomised, controlled trial. Lancet Haematol. 2024 Oct;11(10):e741-e750. doi: 10.1016/S2352-3026(24)00148-0. Epub 2024 Jul 24.","pmid":"39067465","type":"DERIVED"},{"citation":"Thoren K, Menad S, Nouadje G, Mace S. Isatuximab-Specific Immunofixation Electrophoresis Assay to Remove Interference in Serum M-Protein Measurement in Patients with Multiple Myeloma. J Appl Lab Med. 2024 Jul 1;9(4):661-671. doi: 10.1093/jalm/jfae028.","pmid":"38573925","type":"DERIVED"},{"citation":"Facon T, Moreau P, Baker R, Min CK, Leleu X, Mohty M, Karlin L, Armstrong NM, Tekle C, Schwab S, Risse ML, Martin T. Isatuximab plus carfilzomib and dexamethasone in patients with early versus late relapsed multiple myeloma: IKEMA subgroup analysis. Haematologica. 2024 Feb 1;109(2):604-616. doi: 10.3324/haematol.2023.283073.","pmid":"37584290","type":"DERIVED"},{"citation":"Kawano Y, Kim K, Min CK, Koh Y, Ishizawa K, Kim SH, Ito S, Tanaka J, Uchiyama M, Ishida T, Kim JS, Moreau P, Martin T, Tada K, Risse ML, Suzuki K. Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis. Clin Lymphoma Myeloma Leuk. 2023 Oct;23(10):e360-e367. doi: 10.1016/j.clml.2023.06.011. Epub 2023 Jul 3.","pmid":"37479547","type":"DERIVED"},{"citation":"Martin T, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Casca F, Mace S, Risse ML, Moreau P. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. Blood Cancer J. 2023 May 9;13(1):72. doi: 10.1038/s41408-023-00797-8.","pmid":"37156782","type":"DERIVED"},{"citation":"Beksac M, Spicka I, Hajek R, Bringhen S, Jelinek T, Martin T, Mikala G, Moreau P, Symeonidis A, Rawlings AM, van de Velde H, Richardson PG. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022 Nov;122:106948. doi: 10.1016/j.leukres.2022.106948. Epub 2022 Sep 6.","pmid":"36108425","type":"DERIVED"},{"citation":"Moreau P, Dimopoulos MA, Yong K, Mikhael J, Risse ML, Asset G, Martin T. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design. Future Oncol. 2020 Jan;16(2):4347-4358. doi: 10.2217/fon-2019-0431. Epub 2019 Dec 13.","pmid":"31833394","type":"DERIVED"}],"start_date":{"date":"2017-10-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients","url":"https://clinicaltrials.gov/study/NCT03275285"},"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/ikema-nct03275285"}