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
Biocad
390 participants
Jun 15, 2026
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
Plain Language Summary
Simplified for easier understanding
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
BCD-248 subcutaneously, daratumumab intravenously
Daratumumab intravenously, pomalidomide per os, dexamethasone per os
Locations(16)
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NCT07742215