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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
subcutaneously
Overall response rate according to IMWG (International Myeloma Working Group) criteria
Time frame: Up to 24 weeks
Progression-free survival (PFS)
Time frame: Up to 104 weeks
Complete response (CR) rate according to IMWG criteria
Time frame: Up to 3.7 years
MRD (minimal residual disease)-negativity rate
Time frame: Up to 3.7 years
Duration of response
Time frame: Up to 3.7 years
Time to progression
Time frame: Up to 3.7 years
Time to response
Time frame: Up to 3.7 years
Overall survival
Time frame: Up to 3.7 years
Incidence and characteristics of adverse events
Time frame: Up to 3.7 years
Cmax after the first administration
Time frame: up to Day 6
Cmin after the first administration
Time frame: up to Day 6
AUC0-t after the first administration
Time frame: up to Day 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SBHI of the Kaliningrad region "Central City Clinical Hospital"
Kaliningrad, Russia
NOT_YET_RECRUITINGSAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"
Kazan', Russia
NOT_YET_RECRUITINGFSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"
Kirov, Russia
NOT_YET_RECRUITINGRegional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
Krasnoyarsk, Russia
RECRUITINGBranch of the limited liability company "Hadassah Medical LTD"
Moscow, Russia
RECRUITINGCity Clinical Hospital №52 of the Department of Health of the City of Moscow
Moscow, Russia
RECRUITINGFSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
Moscow, Russia
NOT_YET_RECRUITINGJSC "Medsi Group of Companies"
Moscow, Russia
RECRUITINGSBI of health care of the city of Moscow city clinical hospital named after S. P. Botkin of the Department of health of the City of Moscow
Moscow, Russia
NOT_YET_RECRUITINGState budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"
Moscow, Russia
NOT_YET_RECRUITING...and 10 more locations
Ctrough
Time frame: up to 6 months
Soluble BCMA concentration in the blood
Time frame: Up to 6 months
Proportion of subjects with BAbs
Time frame: Up to 3 years
Proportion of subjects with NAbs
Time frame: Up to 3 years