Open-Label Phase 2 Study of BCD-248 Injected Under the Skin to Treat Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the efficacy and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma, a condition where the disease has returned or is resistant to previous therapies. This open-label phase 2 clinical study aims to assess the overall response rate and other important outcomes in this patient population. The study is sponsored by Biocad and focuses on patients who have received multiple prior treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants will receive BCD-248 administered subcutaneously. The study monitors various outcomes including overall response rate up to 24 weeks and progression-free survival up to 104 weeks, among others, over a total duration extending to about 3.7 years for some measures. Pharmacokinetic parameters like Cmax, Cmin, AUC0-t, and Ctrough will be tracked shortly after administration and up to 6 months. Additional assessments include measurement of soluble BCMA levels and the presence of binding and neutralizing antibodies. During the study, participants will undergo regular evaluations including disease assessments based on International Myeloma Working Group criteria, safety monitoring for adverse events, and laboratory tests. Long-term follow-up will include evaluation of response duration, time to response and progression, and overall survival. The study started in December 2024 and is expected to continue until July 2028, providing extended observation for participant outcomes and safety.

An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma