The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and/or refractory multiple myeloma.
Signed informed consent form.
Age ≥18 years.
Documented diagnosis of multiple myeloma according to the IMWG criteria.
Measurable disease at screening.
Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
Use of any investigational medicinal products or medical devices within 30 days or 5 half-lives (whichever is longer) prior to the expected start of the study therapy or planned use of investigational medicinal products or medical devices during participation in this study, except for the use described in this Protocol.
Autologous hematopoietic stem cell transplantation within 12 weeks prior to the expected start of the study therapy or a history of allogenic stem cell transplantation, regardless of when it was performed.
Planned hematopoietic stem cell transplantation before disease progression during this study.
Single group
BCD-248
Drugsubcutaneously
Overall response rate according to IMWG (International Myeloma Working Group) criteria
Progression-free survival (PFS)
Complete response (CR) rate according to IMWG criteria
MRD (minimal residual disease)-negativity rate
Duration of response
