{"preliminary_commentary":{"by_channel":{"x_thread":87,"youtube":85,"podcast":43,"x_video":4,"bluesky_thread":1},"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\": \"NCT03652064\", \"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":"NCT03652064","nct_id":"NCT03652064","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03652064. 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 bortezomib 1.3 milligram per square meter (mg/m\\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 (cycle of 28 days); dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond (each cycle is of 28 days) followed by lenalidomide-dexamethasone (Rd) until disease progression or unacceptable toxicity. Participants aged greater than (\\>)75 years or body mass index (BMI) less than (\\<) 18.5 kilograms per meters (kg/m\\^2) will receive dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle.","label":"Bortezomib + Lenalidomide + Dexamethasone (VRd) and Rd","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive daratumumab 1800 mg as SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3 through 8 and every 4 weeks for Cycle 9 and beyond; bortezomib 1.3 mg/m\\^2 as SC injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9; dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond followed by daratumumab-lenalidomide-dexamethasone (DRd) until disease progression or unacceptable toxicity. Participants aged \\>75 years or BMI \\<18.5 kg/m\\^2 will receive Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle.","label":"Daratumumab + VRd (D-VRd) and DRd","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-04-21","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":395,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Daratumumab","otherNames":["JNJ-54767414","DARZALEX"],"type":"DRUG"},{"name":"Bortezomib","otherNames":["Velcade"],"type":"DRUG"},{"name":"Lenalidomide","otherNames":["Revlimid"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2026-06-02","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-05-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Primary Analysis: Overall Minimal Residual Disease (MRD) Negative Rate","timeFrame":"From randomization (Day 1) up to 27.9 months"},{"measure":"Final Progression-Free Survival (PFS) Analysis : Overall Minimal Residual Disease (MRD) Negative Rate","timeFrame":"From randomization (Day 1) up to 64.8 months"}],"references":[{"citation":"Usmani SZ, Facon T, Hungria V, Bahlis NJ, Venner CP, Braunstein M, Pour L, Marti JM, Basu S, Cohen YC, Matsumoto M, Suzuki K, Hulin C, Grosicki S, Legiec W, Beksac M, Maiolino A, Takamatsu H, Perrot A, Turgut M, Liu W, Wang J, Krevvata M, Stanziola J, Loi M, Van Brummelen EMJ, Lopez-Masi L, Rowe M, Carson RL, Zweegman S. Daratumumab Plus Bortezomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma: Transplant-Ineligible Subgroup Analysis of CEPHEUS. J Clin Oncol. 2026 Sep 25:JCO2600401. doi: 10.1200/JCO-26-00401. Online ahead of print.","pmid":"42789828","type":"DERIVED"},{"citation":"Zweegman S, Facon T, Hungria V, Bahlis NJ, Venner CP, Braunstein M, Pour L, Marti J, Basu S, Cohen YC, Matsumoto M, Suzuki K, Hulin C, Legiec WM, Beksac M, Maiolino A, Takamatsu H, Perrot A, Turgut M, Liu W, Wang J, Van Brummelen E, Krevvata M, Lopez-Masi L, Carey J, Borgsten F, Rowe M, Carson R, Usmani SZ. Daratumumab in Transplant-Ineligible or -Deferred Newly Diagnosed Multiple Myeloma: Minimal Residual Disease in CEPHEUS. Blood Adv. 2026 Jun 3:bloodadvances.2026019937. doi: 10.1182/bloodadvances.2026019937. Online ahead of print.","pmid":"42234958","type":"DERIVED"},{"citation":"Usmani SZ, Facon T, Hungria V, Bahlis NJ, Venner CP, Braunstein M, Pour L, Marti JM, Basu S, Cohen YC, Matsumoto M, Suzuki K, Hulin C, Grosicki S, Legiec W, Beksac M, Maiolino A, Takamatsu H, Perrot A, Turgut M, Ahmadi T, Liu W, Wang J, Chastain K, Vermeulen J, Krevvata M, Lopez-Masi L, Carey J, Rowe M, Carson R, Zweegman S. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS trial. Nat Med. 2025 Apr;31(4):1195-1202. doi: 10.1038/s41591-024-03485-7. Epub 2025 Feb 5.","pmid":"39910273","type":"DERIVED"},{"citation":"Abdallah N, Kumar SK. Up-Front Treatment of Elderly (Age >/=75 Years) and Frail Patients With Multiple Myeloma. J Natl Compr Canc Netw. 2024 Nov;22(9):e247039. doi: 10.6004/jnccn.2024.7039.","pmid":"39536451","type":"DERIVED"}],"start_date":{"date":"2018-11-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy","url":"https://clinicaltrials.gov/study/NCT03652064"},"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/nct03652064"}