{"preliminary_commentary":{"by_channel":{"x_thread":47,"youtube":19,"podcast":9},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02195479\", \"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."},"commentary_summary":null,"drugs_tested":[["daratumumab"]],"indication":"transplant-ineligible newly diagnosed multiple myeloma","name":"ALCYONE","nct_id":"NCT02195479","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=alcyone-nct02195479. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m\\^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m\\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.","label":"Treatment Arm A (VMP Alone)","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive velcade 1.3 mg/m\\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m\\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.","label":"Treatment Arm B (D-VMP)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-08-07","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":706,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Velcade","otherNames":[],"type":"DRUG"},{"name":"Melphalan","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Daratumumab IV","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Daratumumab SC","otherNames":[],"type":"DRUG"}],"last_update":"2025-08-22","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2017-11-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS)","timeFrame":"From randomization (Day -3) up to 2.4 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":"Mateos MV, San-Miguel J, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Yoon SS, Iosava G, Fujisaki T, Garg M, Ngo M, Katz EG, Krevvata M, Bolyard K, Carson R, Borgsten F, Dimopoulos MA. Bortezomib, melphalan, and prednisone with or without daratumumab in transplant-ineligible patients with newly diagnosed multiple myeloma (ALCYONE): final analysis of an open-label, randomised, multicentre, phase 3 trial. Lancet Oncol. 2025 May;26(5):596-608. doi: 10.1016/S1470-2045(25)00018-X. Epub 2025 Apr 9.","pmid":"40220771","type":"DERIVED"},{"citation":"Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Yoon SS, Iosava G, Fujisaki T, Garg M, Iida S, Blade J, Ukropec J, Pei H, Van Rampelbergh R, Kudva A, Qi M, San-Miguel J. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):785-798. doi: 10.1016/j.clml.2021.06.005. Epub 2021 Jun 18.","pmid":"34344638","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":"Knop S, Mateos MV, Dimopoulos MA, Suzuki K, Jakubowiak A, Doyen C, Lucio P, Nagy Z, Usenko G, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Losava G, Fujisaki T, Garg M, Wang J, Wroblewski S, Kudva A, Gries KS, Fastenau J, San-Miguel J, Cavo M. Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial. BMC Cancer. 2021 Jun 2;21(1):659. doi: 10.1186/s12885-021-08325-2.","pmid":"34078314","type":"DERIVED"},{"citation":"Mateos MV, Cavo M, Blade J, Dimopoulos MA, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Krevvata M, Chen Y, Wang J, Kudva A, Ukropec J, Wroblewski S, Qi M, Kobos R, San-Miguel J. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2020 Jan 11;395(10218):132-141. doi: 10.1016/S0140-6736(19)32956-3. Epub 2019 Dec 10.","pmid":"31836199","type":"DERIVED"},{"citation":"Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Kaplan P, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Chiu C, Wang J, Carson R, Crist W, Deraedt W, Nguyen H, Qi M, San-Miguel J; ALCYONE Trial Investigators. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018 Feb 8;378(6):518-528. doi: 10.1056/NEJMoa1714678. Epub 2017 Dec 12.","pmid":"29231133","type":"DERIVED"}],"start_date":{"date":"2014-12-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT02195479"},"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/alcyone-nct02195479"}