RecruitingPhase 3NCT07742215

A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)

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


Sponsor

Biocad

Enrollment

390 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BCD-248 + daratumumab and a drug called Daratumumab + pomalidomide + dexamethasone for people with myeloma, multiple. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCD-248 + daratumumab

BCD-248 subcutaneously, daratumumab intravenously

DRUGDaratumumab + 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

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NCT07742215


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