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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed informed consent form.
• Age ≥ 18 years at the time of signing of the informed consent form.
• Documented diagnosis of multiple myeloma according to IMWG criteria
• Measurable disease at screening:
‣ M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
⁃ light chain myeloma: serum involved FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio .
• At least a partial response according to IMWG criteria to at least 1 prior line of therapy.
• Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy
• ECOG score 0-2.
• Not pregnant and willing to use contraception.
• Consent to bone marrow biopsy in the study.
Locations
Other Locations
Russian Federation
Chelyabinsk Regional Clinical Hospital
RECRUITING
Chelyabinsk
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
RECRUITING
Kemerovo
Regional Clinical Hospital
RECRUITING
Krasnoyarsk
Moscow City Clinical Hospital 52
RECRUITING
Moscow
S.P. Botkin Moscow City Clinical Hospital
RECRUITING
Moscow
Almazov National Medical Research Centre
RECRUITING
Saint Petersburg
N.N. Petrov National Medicine Research Center of oncology
RECRUITING
Saint Petersburg
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
RECRUITING
Saint Petersburg
St Petersburg State I.P. Pavlov Medical University
RECRUITING
Saint Petersburg
State budgetary healthcare institution Leningrad Regional Clinical Hospital
RECRUITING
Saint Petersburg
Samara State Medical University
RECRUITING
Samara
Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
RECRUITING
Sochi
Bashkir State Medical University
RECRUITING
Ufa
Sverdlovsk Regional Clinical Hospital No. 1
RECRUITING
Yekaterinburg
Time Frame
Start Date:2023-12-21
Estimated Completion Date:2026-07
Participants
Target number of participants:252
Treatments
Experimental: BCD-264
Blinded period: BCD-264 (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.~Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks
Active_comparator: Darzalex
Blinded period: Darzalex (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.~Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks