{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"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":false},"name":"NCT03301220","nct_id":"NCT03301220","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03301220. 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":"Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.","label":"Arm A: Active Monitoring","type":"NO_INTERVENTION"},{"description":"Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion.","label":"Arm B: Daratumumab SC","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-05-04","type":"ACTUAL"},"conditions":["Smoldering Multiple Myeloma"],"enrollment":{"count":390,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Daratumumab SC: daratumumab + rHuPH20","type":"DRUG"}],"last_update":"2026-06-08","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-05-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)","timeFrame":"From randomization (Day -5) up to 77 months"}],"references":[{"citation":"Suzuki K, Kosugi H, Ito T, Takamatsu Y, Voorhees PM, Rajkumar SV, Ito M, Sakai C, Takahashi M, Nakatogawa T, Dennis R, Carson R, Dimopoulos MA. Japanese subgroup analysis of AQUILA trial: daratumumab vs active monitoring in high-risk smoldering multiple myeloma. Jpn J Clin Oncol. 2026 Sep 16:hyag146. doi: 10.1093/jjco/hyag146. Online ahead of print.","pmid":"42747040","type":"DERIVED"},{"citation":"Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, Lindsay J, Baker RI, Suzuki K, Kosugi H, Levin MD, Beksac M, Stockerl-Goldstein K, Oriol A, Mikala G, Garate G, Theunissen K, Spicka I, Mylin AK, Bringhen S, Uttervall K, Pula B, Medvedova E, Cowan AJ, Moreau P, Mateos MV, Goldschmidt H, Ahmadi T, Sha L, Cortoos A, Katz EG, Rousseau E, Li L, Dennis RM, Carson R, Rajkumar SV; AQUILA Investigators. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. N Engl J Med. 2025 May 8;392(18):1777-1788. doi: 10.1056/NEJMoa2409029. Epub 2024 Dec 9.","pmid":"39652675","type":"DERIVED"}],"start_date":{"date":"2017-11-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03301220"},"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/nct03301220"}