nctId: NCT06296121 id: BCD-264-2 briefTitle: A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma acronym: DARVIVA overallStatus: RECRUITING date: 2023-12-21 date: 2025-01 date: 2026-07 date: 2024-03-06 date: 2024-03-06 name: Biocad class: INDUSTRY briefSummary: The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: BCD-264 name: Darzalex measure: Overall response rate according to IMWG (International Myeloma Working Group) criteria measure: Stringent complete response rate according to IMWG criteria measure: Complete response (CR) rate according to IMWG criteria measure: Very good partial response (VGPR) rate according to IMWG criteria measure: Duration of response measure: Progression-free survival measure: Time to progression measure: Time to response measure: Overall survival measure: Incidence and characteristics of adverse events measure: Proportion of subjects with BAbs/Nabs measure: Time to BAb/NAb development measure: AUC0-168 measure: AUC0-∞ measure: AUC0-336, ss measure: Cmax measure: Cmax, ss measure: Tmax measure: T1/2 measure: Vd measure: Ctrough, ss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chelyabinsk Regional Clinical Hospital status: RECRUITING city: Chelyabinsk country: Russian Federation name: Alexander Korobkin role: CONTACT phone: +7 (351) 749-37-10 email: chelokb@mail.ru lat: 55.15402 lon: 61.42915 facility: Sverdlovsk Regional Clinical Hospital No. 1 status: RECRUITING city: Ekaterinburg country: Russian Federation name: Tatiana Konstantinova role: CONTACT phone: +7 (343) 363-03-03 email: sokbinfo@mail.ru lat: 56.8519 lon: 60.6122 facility: Kuzbass Regional Clinical Hospital named after S.V. Belyaev status: RECRUITING city: Kemerovo country: Russian Federation name: Marina Kosinova role: CONTACT phone: 8(384-2)39-65-33 email: o5-guz-kokb@kuzdrav.ru lat: 55.33333 lon: 86.08333 facility: Regional Clinical Hospital status: RECRUITING city: Krasnoyarsk country: Russian Federation name: Elena Martynova role: CONTACT phone: +7 (391) 202-68-50 email: kkb@medgorod.ru lat: 56.01839 lon: 92.86717 facility: Moscow City Clinical Hospital 52 status: RECRUITING city: Moscow country: Russian Federation name: Elena Misyurina role: CONTACT phone: +7 (495) 870-36-04 email: gkb52international@gmail.com lat: 55.75222 lon: 37.61556 facility: S.P. Botkin Moscow City Clinical Hospital status: RECRUITING city: Moscow country: Russian Federation name: Vadim Doronin role: CONTACT phone: +7 495 945 9972 email: botkinhospital@zdrav.mos.ru lat: 55.75222 lon: 37.61556 facility: Almazov National Medical Research Centre status: RECRUITING city: Saint Petersburg country: Russian Federation name: Yuri Osipov role: CONTACT phone: +7 (812) 660-37-06 email: fmrc@almazovcentre.ru lat: 59.93863 lon: 30.31413 facility: N.N. Petrov National Medicine Research Center of oncology status: RECRUITING city: Saint Petersburg country: Russian Federation name: Ilya Zyuzgin role: CONTACT phone: +7(812)43-99-555 email: oncl@rion.spb.ru lat: 59.93863 lon: 30.31413 facility: Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency status: RECRUITING city: Saint Petersburg country: Russian Federation name: Sergei Voloshin role: CONTACT phone: +78123097982 email: bloodscience@mail.ru lat: 59.93863 lon: 30.31413 facility: St Petersburg State I.P. Pavlov Medical University status: RECRUITING city: Saint Petersburg country: Russian Federation name: Ivan Moiseev role: CONTACT phone: (812) 338 67 48 email: opmu@spb-gmu.ru lat: 59.93863 lon: 30.31413 facility: State budgetary healthcare institution Leningrad Regional Clinical Hospital status: RECRUITING city: Saint Petersburg country: Russian Federation name: Margarita Ulyanova role: CONTACT phone: 8 (812) 670-18-88 email: lokb@47lokb.ru lat: 59.93863 lon: 30.31413 facility: Samara State Medical University status: RECRUITING city: Samara country: Russian Federation name: Igor Davydkin role: CONTACT phone: 8 (846) 374-91-00 email: clinica@samsmu.ru lat: 53.20007 lon: 50.15 facility: Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory status: RECRUITING city: Sochi country: Russian Federation name: Dmitrii Kirtbaya role: CONTACT phone: (862) 261-43-89 email: onko13@sochi.com lat: 43.59917 lon: 39.72569 facility: Bashkir State Medical University status: RECRUITING city: Ufa country: Russian Federation name: Bulat Bakirov role: CONTACT phone: 8 (347) 272-41-73 email: rectorat@bashgmu.ru lat: 54.74306 lon: 55.96779 hasResults: False