{"preliminary_commentary":{"by_channel":{"x_thread":10,"youtube":6,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01668719\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"S1211","nct_id":"NCT01668719","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=s1211-nct01668719. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).\n\nMAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm I (bortezomib, lenalidomide, dexamethasone)","type":"ACTIVE_COMPARATOR"},{"description":"INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2025-09-22","type":"ACTUAL"},"conditions":["DS Stage I Plasma Cell Myeloma","DS Stage II Plasma Cell Myeloma","DS Stage III Plasma Cell Myeloma"],"enrollment":{"count":142,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Bortezomib","otherNames":["[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid","LDP 341","MLN341","PS-341","PS341","Velcade"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":["Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Fluorodelta","Fortecortin","Gammacorten","Hexadecadrol","Hexadrol","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","Visumetazone"],"type":"DRUG"},{"name":"Elotuzumab","otherNames":["BMS-901608","HuLuc63","PDL-063","PDL063"],"type":"BIOLOGICAL"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Lenalidomide","otherNames":["CC-5013","CC5013","CDC 501","Revlimid"],"type":"DRUG"}],"last_update":"2026-04-28","lead_sponsor":"SWOG Cancer Research Network","official_title":"A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide With or Without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2020-02-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone","timeFrame":"time from first participants randomized until at least 6 patients were evaluable for DLTs. DLTs were assessed only during Cycle 1 (21 days)"},{"measure":"Progression-free Survival","timeFrame":"Up to 6 years post registration"}],"references":[{"citation":"Banerjee R, Sexton R, Cowan AJ, Rosenberg AS, Ailawadhi S, Rajkumar SV, Kumar S, Dispenzieri A, Lonial S, Durie BGM, Richardson PG, Usmani SZ, Hoering A, Orlowski RZ. Dexamethasone dose intensity does not impact outcomes in newly diagnosed multiple myeloma: a secondary SWOG analysis. Blood. 2025 Jan 2;145(1):75-84. doi: 10.1182/blood.2024025939.","pmid":"39321347","type":"DERIVED"},{"citation":"Usmani SZ, Hoering A, Ailawadhi S, Sexton R, Lipe B, Hita SF, Valent J, Rosenzweig M, Zonder JA, Dhodapkar M, Callander N, Zimmerman T, Voorhees PM, Durie B, Rajkumar SV, Richardson PG, Orlowski RZ; SWOG1211 Trial Investigators. Bortezomib, lenalidomide, and dexamethasone with or without elotuzumab in patients with untreated, high-risk multiple myeloma (SWOG-1211): primary analysis of a randomised, phase 2 trial. Lancet Haematol. 2021 Jan;8(1):e45-e54. doi: 10.1016/S2352-3026(20)30354-9. Epub 2020 Dec 22.","pmid":"33357482","type":"DERIVED"}],"start_date":{"date":"2012-11"},"study_type":"INTERVENTIONAL","title":"S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT01668719"},"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/s1211-nct01668719"}