{"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":[["subcutaneous daratumumab"]],"indication":"relapsed or refractory multiple myeloma","name":"NCT02519452","nct_id":"NCT02519452","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02519452. 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":"Participants will receive 1200 mg (daratumumab 1200 milligram (mg) with Recombinant Human Hyaluronidase \\[rHuPH20\\] 30,000 U) via mixing immediately before Subcutaneous (SC) infusion once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression.","label":"Part 1: Cohort 1","type":"EXPERIMENTAL"},{"description":"Participants will receive 1800 mg (daratumumab 1800 milligram (mg) with Recombinant Human Hyaluronidase \\[rHuPH20\\] 45,000 U) via mixing immediately before SC infusion once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression.","label":"Part 1: Cohort 2","type":"EXPERIMENTAL"},{"description":"Participants will receive mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery at a dose which will be decided by Study Evaluation Team (SET) once weekly by SC infusion in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression. Also up to three additional optional cohorts (Cohorts 3b, 3c, and 3d) may be enrolled to repeat a dose level of daratumumab.","label":"Part 1: Cohort 3","type":"EXPERIMENTAL"},{"description":"Participants will receive 1800 mg co-formulated daratumumab and rHuPH20 preparation initially administered by SC injection once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles. The dose level and schedule for any additional cohorts would be selected based on the daratumumab pharmacokinetic profile and safety profile (reviewed by the SET) that will be observed in Cohort 4.","label":"Part 2: Cohort 4","type":"EXPERIMENTAL"},{"description":"Participants will receive co-formulated daratumumab 1800 mg and rHuPH20 preparation (Dara-CF) initially administered by SC injection once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles.","label":"Part 3: Dara-CF 1800 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-04-03","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":120,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Daratumumab Subcutaneous (SC) Administration","otherNames":[],"type":"DRUG"},{"name":"Recombinant Human Hyaluronidase [rHuPH20]) SC Administration","otherNames":[],"type":"DRUG"}],"last_update":"2025-05-23","lead_sponsor":"Janssen Research & Development, LLC","official_title":"An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2017-12-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Serum Trough Concentrations (Ctrough) of Daratumumab","timeFrame":"Up to cycle 3 (each cycle 28 days) Day 1"},{"measure":"Part 1, 2 and 3: Number of Participants with Adverse Events (AEs) and Serious AEs","timeFrame":"Screening up to follow-up (30 days after last dose administration) (Approximately up to 3.4 years)"}],"references":[{"citation":"Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6.","pmid":"37022569","type":"DERIVED"},{"citation":"Nahi H, Usmani SZ, Mateos MV, van de Donk NWCJ, Oriol A, Plesner T, Bandyopadhyay N, Hellemans P, Tromp B, Nnane I, Zemlickis D, Chari A, Moreau P. Corticosteroid tapering is a safe approach in patients with relapsed or refractory multiple myeloma receiving subcutaneous daratumumab: part 3 of the open-label, multicenter, phase 1b PAVO study. Leuk Lymphoma. 2023 Feb;64(2):468-472. doi: 10.1080/10428194.2022.2148221. Epub 2023 Jan 2. No abstract available.","pmid":"36593729","type":"DERIVED"},{"citation":"Usmani SZ, Nahi H, Mateos MV, van de Donk NWCJ, Chari A, Kaufman JL, Moreau P, Oriol A, Plesner T, Benboubker L, Hellemans P, Masterson T, Clemens PL, Luo M, Liu K, San-Miguel J. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019 Aug 22;134(8):668-677. doi: 10.1182/blood.2019000667. Epub 2019 Jul 3.","pmid":"31270103","type":"DERIVED"}],"start_date":{"date":"2015-10-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT02519452"},"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/nct02519452"}