The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma. The study will be conducted in a population of male and female subjects aged 18 years and older, with confirmed symptomatic multiple myeloma with measurable disease, who have received one prior line of therapy that included a proteasome inhibitor and lenalidomide and were refractory to lenalidomide, or who have received two or three prior lines of therapy that included a proteasome inhibitor and lenalidomide, with disease progression during or after the last line of therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
390
BCD-248 subcutaneously, daratumumab intravenously
Daratumumab intravenously, pomalidomide per os, dexamethasone per os
SI "Republican Scientific and Practical Center for Radiation Medicine and Human Ecology"
Homyel, Belarus
RECRUITINGSBHI "Chelyabinsk regional clinical hospital"
Chelyabinsk, Russia
RECRUITINGSBHI "Regional oncological dispensary"
Irkutsk, Russia
RECRUITINGSAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Kazan', Russia
RECRUITINGRegional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
Krasnoyarsk, Russia
RECRUITINGBranch Office of Hadassah Medical Ltd.
Moscow, Russia
RECRUITINGBHI of the Omsk region "Clinical Oncological Dispensary"
Omsk, Russia
RECRUITINGSt. Petersburg State Healthcare Institution "City Hospital No. 15"
Saint Petersburg, Russia
RECRUITINGFSBI "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia
RECRUITINGFSBI "Russian Research Institute of Hematology and Transfusiology" of the Federal Medical and Biological Agency
Saint Petersburg, Russia
RECRUITING...and 6 more locations
Frequency of MRD negativity by flow cytometry at 12 months from the start of therapy
Time frame: up to 12 months
Progression-free survival according to the International Myeloma Working Group (IMWG) criteria
The disease status and treatment efficacy will be analyzed according to the International Myeloma Working Group (IMWG) criteria for response and minimal residual disease assessment in multiple myeloma proposed in 2006 and modified in 2011 and 2016
Time frame: up to 36 months
Overall response rate (at least partial response) according to the IMWG criteria.
Time frame: up to 5 years
Frequency of at least a complete response according to the IMWG criteria.
Time frame: up to 5 years
Frequency of at least a very good partial response according to the IMWG criteria.
Time frame: up to 5 years
Frequency of MRD negativity.
Time frame: up to 5 years
Frequency of sustained MRD negativity.
Time frame: up to 5 years
Time to response.
Time frame: up to 5 years
Duration of response.
Time frame: up to 5 years
Time to progression.
Time frame: up to 5 years
Overall survival.
Time frame: up to 5 years
Ctrough of BCD-248.
Pharmacokinetics
Time frame: up to 12 months
Changes over time in the concentration of soluble BCMA in the blood.
Pharmacodynamics
Time frame: up to 12 months
Changes over time in lymphocyte populations.
Pharmacodynamics
Time frame: up to 12 months
Proportion of participants with detected BAbs and NAbs to BCD-248
Immunogenicity
Time frame: up to 5 years
Incidence and characteristics of adverse events
ITo assess the safety of the study therapy, vital signs will be assessed, physical, laboratory and instrumental examinations will be performed, and the presence and characteristics of adverse events will be assessed
Time frame: up to 5 years
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