OncoMatch/Clinical Trials/NCT06296121
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
Is NCT06296121 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BCD-264 and Darzalex for multiple myeloma.
Treatment: BCD-264 · Darzalex — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy
Must have received: immunomodulatory drug
previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy
Cannot have received: anti-CD38 therapy (daratumumab)
Prior treatment with daratumumab or other anti-CD38 therapy.
Cannot have received: any treatment for multiple myeloma
Exception: except for a short course of glucocorticoids
Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
Cannot have received: autologous hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
Cannot have received: allogeneic hematopoietic stem cell transplantation
Allogeneic hematopoietic stem cell transplantation, regardless of timing.
Cannot have received: scheduled hematopoietic stem cell transplantation
Exception: prior to progressive disease during this study
Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
Cannot have received: plasmapheresis
Plasmapheresis within 28 days prior to randomization.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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