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