drugset / Trial / NCT06296121

A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

NCT06296121

Phase 3 Recruiting 252 enrolled Biocad
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-12-21
Primary completion
2025-01
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-264 Unknown 16 mg/kg Intravenous

Indications