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A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)
Sponsor: Biocad
Summary
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.
Official title: A Phase III Open-Label, Randomized Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab Versus Daratumumab, Pomalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2026-06-15
Completion Date
2032-10
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
BCD-248 + daratumumab
BCD-248 subcutaneously, daratumumab intravenously
Daratumumab + pomalidomide + dexamethasone
Daratumumab intravenously, pomalidomide per os, dexamethasone per os
Locations (16)
SI "Republican Scientific and Practical Center for Radiation Medicine and Human Ecology"
Homyel, Belarus
SBHI "Chelyabinsk regional clinical hospital"
Chelyabinsk, Russia
SBHI "Regional oncological dispensary"
Irkutsk, Russia
SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Kazan', Russia
Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
Krasnoyarsk, Russia
Branch Office of Hadassah Medical Ltd.
Moscow, Russia
BHI of the Omsk region "Clinical Oncological Dispensary"
Omsk, Russia
St. Petersburg State Healthcare Institution "City Hospital No. 15"
Saint Petersburg, Russia
FSBI "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia
FSBI "Russian Research Institute of Hematology and Transfusiology" of the Federal Medical and Biological Agency
Saint Petersburg, Russia
SBHI "Leningrad Regional Clinical Hospital"
Saint Petersburg, Russia
FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
Samara, Russia
FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
Saratov, Russia
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"
Smolensk, Russia
State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region
Sochi, Russia
SBHI "Republican Clinical Hospital named G.G. Kuvatov"
Ufa, Russia