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Brief Title: A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
Official Title: A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma
Study ID: NCT06296121
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chelyabinsk Regional Clinical Hospital, Chelyabinsk, , Russian Federation
Sverdlovsk Regional Clinical Hospital No. 1, Ekaterinburg, , Russian Federation
Kuzbass Regional Clinical Hospital named after S.V. Belyaev, Kemerovo, , Russian Federation
Regional Clinical Hospital, Krasnoyarsk, , Russian Federation
Moscow City Clinical Hospital 52, Moscow, , Russian Federation
S.P. Botkin Moscow City Clinical Hospital, Moscow, , Russian Federation
Almazov National Medical Research Centre, Saint Petersburg, , Russian Federation
N.N. Petrov National Medicine Research Center of oncology, Saint Petersburg, , Russian Federation
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency, Saint Petersburg, , Russian Federation
St Petersburg State I.P. Pavlov Medical University, Saint Petersburg, , Russian Federation
State budgetary healthcare institution Leningrad Regional Clinical Hospital, Saint Petersburg, , Russian Federation
Samara State Medical University, Samara, , Russian Federation
Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory, Sochi, , Russian Federation
Bashkir State Medical University, Ufa, , Russian Federation