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

Recruiting Phase 3 Interventional Study
Multiple Myeloma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
252 (estimated)
Sponsor
Biocad · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent form. 2. Age ≥ 18 years at the time of signing of the informed consent form. 3. Documented diagnosis of multiple myeloma according to IMWG criteria 4. Measurable disease at screening: 1. M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ …
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