{"preliminary_commentary":{"by_channel":{"x_thread":123,"youtube":65,"podcast":25,"x_video":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02252172\", \"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."},"name":"NCT02252172","nct_id":"NCT02252172","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02252172. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.","label":"Lenalidomide and Dexamethasone (Rd)","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.","label":"Daratumumab + Lenalidomide + Dexamethasone (DRd)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2024-10-02","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":737,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Daratumumab IV","otherNames":["JNJ-54767414"],"type":"DRUG"},{"name":"Lenalidomide","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Daratumumab SC","otherNames":["JNJ-54767414"],"type":"DRUG"}],"last_update":"2025-10-20","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2018-09-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)"}],"references":[{"citation":"Bahlis N, Facon T, San-Miguel J, Usmani SZ, Dimopoulos MA, Moreau P, Zweegman S, Perrot A, Manier S, Chari A, Raje N, Orlowski RZ, Goldschmidt H, Basu S, Hulin C, Weisel K, Mohty M, Leleu X, Plesner T, Jakubowiak A, Cook G, Quach H, Venner CP, Cavo M, Ngo M, Bolyard K, Carson R, Borgsten F, Mateos MV, Kumar SK. Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE. Blood Adv. 2026 Jul 14;10(13):4541-4550. doi: 10.1182/bloodadvances.2025019323.","pmid":"42085642","type":"DERIVED"},{"citation":"Facon T, Moreau P, Weisel K, Goldschmidt H, Usmani SZ, Chari A, Plesner T, Orlowski RZ, Bahlis N, Basu S, Hulin C, Quach H, O'Dwyer M, Perrot A, Jacquet C, Venner CP, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Cook G, Wang G, Pei H, Krevvata M, Carson R, Borgsten F, Kumar SK. Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia. 2025 Apr;39(4):942-950. doi: 10.1038/s41375-024-02505-2. Epub 2025 Feb 27.","pmid":"40016302","type":"DERIVED"},{"citation":"Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, Wang G, Gupta-Werner N, Kaila S, Pei H, Matt K, Gries KS, Carson R, Borgsten F, Weisel K. Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Treated With Daratumumab, Lenalidomide, and Dexamethasone: MAIA Final Analysis of Patient-Reported Outcomes. Eur J Haematol. 2025 May;114(5):883-889. doi: 10.1111/ejh.14392. Epub 2025 Feb 14.","pmid":"39952901","type":"DERIVED"},{"citation":"Moreau P, Facon T, Usmani SZ, Bahlis N, Raje N, Plesner T, Orlowski RZ, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Tiab M, Macro M, Frenzel L, Leleu X, Wang G, Pei H, Krevvata M, Carson R, Borgsten F, Kumar SK. Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: analysis of key subgroups of the MAIA study. Leukemia. 2025 Mar;39(3):710-719. doi: 10.1038/s41375-024-02506-1. Epub 2025 Jan 15.","pmid":"39815052","type":"DERIVED"},{"citation":"Almansour SA, Alqudah MAY, Abuhelwa Z, Al-Shamsi HO, Alhuraiji A, Semreen MH, Bustanji Y, Alzoubi KH, Modi ND, Mckinnon RA, Sorich MJ, Hopkins AM, Abuhelwa AY. Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials. Ther Adv Med Oncol. 2024 Sep 2;16:17588359241275387. doi: 10.1177/17588359241275387. eCollection 2024.","pmid":"39229471","type":"DERIVED"},{"citation":"Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, Perrot A, Weisel K, Raje N, Macro M, Frenzel L, Leleu X, Wang J, Rampelbergh RV, Uhlar CM, Vermeulen J, Duran J, Borgsten F, Usmani SZ. Plain language summary of the MAIA study of daratumumab plus lenalidomide and dexamethasone for the treatment of people with newly diagnosed multiple myeloma. Future Oncol. 2023 Apr;19(13):887-895. doi: 10.2217/fon-2023-0082. Epub 2023 May 22.","pmid":"37212642","type":"DERIVED"},{"citation":"Mateos MV, Rigaudeau S, Basu S, Spicka I, Schots R, Wrobel T, Cook G, Beksac M, Gries KS, Kudva A, Tromp B, Van Rampelbergh R, Pei H, Wroblewski S, Carson R, Delioukina M, White D. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma. J Oncol Pharm Pract. 2023 Jul;29(5):1172-1177. doi: 10.1177/10781552221103551. Epub 2022 Sep 6.","pmid":"36067063","type":"DERIVED"},{"citation":"Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.","pmid":"34655533","type":"DERIVED"},{"citation":"Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.","pmid":"34289038","type":"DERIVED"},{"citation":"San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.","pmid":"34269818","type":"DERIVED"},{"citation":"Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.","pmid":"33326255","type":"DERIVED"},{"citation":"Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.","pmid":"31141632","type":"DERIVED"}],"start_date":{"date":"2015-02-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT02252172"},"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/nct02252172"}