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

Recruiting Phase 3 Interventional Study
Myeloma Multiple
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
390 (estimated)
Sponsor
Biocad · Industry
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About This Trial
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 diseas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Signed informed consent form. * Age ≥18 years. * Documented diagnosis of multiple myeloma according to the IMWG criteria. * Measurable disease at screening. * At least 1, but not more than 3 prior lines of antimyeloma therapy, including lenalidomide and a proteasome inhibitor.…
Contacts

Evgeniia Mikhailova

+79110812368

mikhailova@biocad.ru

CONTACT