{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03275103","nct_id":"NCT03275103","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03275103. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Study drug will be administered intravenously on a 21-day cycle. The step-up dose will be given on Cycle 1 Day 1 and the target dose will be given on C1D8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.","label":"Arm A: Single Step Dose Escalation for Cevostamab","type":"EXPERIMENTAL"},{"description":"In Cycle 1, participants will receive 2 step-up doses and a target dose. The step-up dose will be given on Cycle 1 Day 1 and C1D8. The target dose will be given on C1D15. 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An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.","label":"Arm E: Expansion Phase for Tocilizumab Pretreatment","type":"EXPERIMENTAL"},{"description":"The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.","label":"Arm F: Single Step Dose Expansion for Cevostamab","type":"EXPERIMENTAL"},{"description":"The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.","label":"Arm G: Double Step Dose Expansion for Cevostamab","type":"EXPERIMENTAL"},{"description":"In Cycle 1, participants will receive 3 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 2-4, 8, and 9-11. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.","label":"Arm H: Triple Step Dose Escalation for Cevostamab","type":"EXPERIMENTAL"},{"description":"The triple step dose expansion stage of the study may use the dosing and assessment schedule from the triple step dose escalation arm in Cycle 1, based on data from Arm H.","label":"Arm I: Triple Step Dose Expansion for Cevostamab","type":"EXPERIMENTAL"},{"description":"All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.","label":"Arm J: Expansion Phase for Tocilizumab Pretreatment","type":"EXPERIMENTAL"},{"description":"In Cycle 1, participants will receive 2 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 4, and 8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.","label":"Arm K: Compressed Double Step Dose Expansion for Cevostamab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-01-07","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":355,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Cevostamab","otherNames":["BFCR4350A; RO7187797"],"type":"DRUG"},{"name":"Tocilizumab","otherNames":["Actemra/RoActemra"],"type":"DRUG"}],"last_update":"2026-02-05","lead_sponsor":"Genentech, Inc.","official_title":"An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of Cevostamab (BFCR4350A) in Patients With Relapsed or Refractory Multiple Myeloma","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2026-01-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants with Adverse Events (AEs)","timeFrame":"Up to approximately 8 years"},{"measure":"Percentage of Participants With Dose-Limiting Toxicities (DLTs)","timeFrame":"Up to approximately 8 years"},{"measure":"Arms E and J Only: Incidence and Severity of Cytokine-release Syndrome (CRS) Following Tocilizumab Premedication Followed by Treatment with Cevostamab","timeFrame":"Up to approximately 8 years"}],"references":[{"citation":"Cohen AD, Richter J, Trudel S, Lesokhin A, Laubach JP, Thomas SK, Harrison SJ, Costa LJ, Spencer A, Fonseca R, Forsberg PA, Berdeja JG, Kaedbey R, Bahlis NJ, Rodriguez-Otero P, Mateos MV, Tyagi T, Samineni D, Liu W, Nakamura R, Choeurng V, Wong C, Cooper J, Krishnan A. FcRH5xCD3 bispecific antibody cevostamab in relapsed or refractory multiple myeloma: a phase 1 trial. Nat Med. 2026 Aug;32(8):2909-2917. doi: 10.1038/s41591-026-04522-3. Epub 2026 Jul 22.","pmid":"42487061","type":"DERIVED"}],"start_date":{"date":"2017-09-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)","url":"https://clinicaltrials.gov/study/NCT03275103"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03275103"}