{"commentary":{"count":8,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":7,"youtube":1},"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\": \"NCT02513186\", \"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":"NCT02513186","nct_id":"NCT02513186","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02513186. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"VCDI cohort: Isatuximab (escalating dose) + bortezomib + cyclophosphamide + dexamethasone (VCDI): Induction phase will be 50 weeks (12 cycles). The duration of a cycle will be 42 days (6 weeks) for Cycle 1 (C1) and 28 days (4 weeks) for subsequent cycles. The duration of a cycle of the maintenance phase will be 28 days (4 weeks). After C12, isatuximab will be administered at its initial assigned dose and dexamethasone once every 28 days.\n\nVRDI cohort parts A and B: Isatuximab + bortezomib + dexamethasone + lenalidomide (VRDI): Induction phase will be 24 weeks (4 cycles at 6 weeks/cycle). The duration of a cycle of the maintenance phase will be 28 days (4 weeks). Maintenance therapy may continue until disease progression, unacceptable AE or patient willingness to discontinue.\n\nVRDI Part A: Enrollment to begin after the VCDI cohort is completed.\n\nVRDI Part B: Enrollment to begin after the VRDI part A is completed.","label":"Isatuximab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-01-22","type":"ACTUAL"},"conditions":["Plasma Cell Myeloma"],"enrollment":{"count":90,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"lenalidomide","type":"DRUG"},{"name":"bortezomib","type":"DRUG"},{"name":"cyclophosphamide","type":"DRUG"},{"name":"dexamethasone","type":"DRUG"},{"name":"isatuximab SAR650984","type":"DRUG"}],"last_update":"2024-01-29","lead_sponsor":"Sanofi","official_title":"A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2022-01-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Assessment of dose-limiting toxicities (DLTs) in VCDI cohort","timeFrame":"Up to 6 weeks per treated patient"},{"measure":"Overall response rate (VCDI)","timeFrame":"Up to 34 weeks of treatment (induction phase)"},{"measure":"Complete response rate (VCDI)","timeFrame":"Up to 34 weeks of treatment (induction phase)"},{"measure":"Complete response rate (VRDI)","timeFrame":"Up to 104 weeks of treatment (induction and maintenance phase) in VRDI part A and part B cohorts"}],"references":[{"citation":"Ocio EM, Perrot A, Moreau P, Mateos MV, Bringhen S, Martinez-Lopez J, Karlin L, Oprea C, Li Y, Kodas E, San-Miguel J. Plain language summary of a study on 30-minute intravenous infusion of isatuximab in people with newly diagnosed multiple myeloma. Future Oncol. 2026 May;22(11):1235-1246. doi: 10.1080/14796694.2026.2652723. Epub 2026 Apr 27.","pmid":"42041169","type":"DERIVED"},{"citation":"Ocio EM, Perrot A, Bories P, San-Miguel JF, Blau IW, Karlin L, Martinez-Lopez J, Wang SY, Bringhen S, Marcatti M, Mateos MV, Rodriguez-Otero P, Oliva S, Nogai A, Le Roux N, Dong L, Mace S, Gassiot M, Fitzmaurice T, Oprea C, Moreau P. Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation. Leukemia. 2023 Jul;37(7):1521-1529. doi: 10.1038/s41375-023-01936-7. Epub 2023 Jun 14.","pmid":"37316728","type":"DERIVED"}],"start_date":{"date":"2015-09-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation","url":"https://clinicaltrials.gov/study/NCT02513186"},"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/nct02513186"}