NCT06296121

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

Name: Clinical Trial NCT06296121
Creator: Biocad
Keywords: Multiple Myeloma, BCD-264, Phase 3, drug, clinical trial, Russian Federation

A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma

Biocad·Phase 3·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Multiple Myeloma
Drug/Device/Intervention: BCD-264
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Biocad
Location: Chelyabinsk,Ekaterinburg,Kemerovo,Krasnoyarsk,Moscow,Moscow,Saint Petersburg,Saint Petersburg,Saint Petersburg,Saint Petersburg,Saint Petersburg,Samara,Sochi,Ufa, Russian Federation

Timeline & enrollment

Phase: Phase 3
Start date: Dec 21, 2023
End date: Jul 01, 2026
Enrollment: 252 participants

Primary outcome

Overall response rate according to IMWG (International Myeloma Working Group) criteria

Summary

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.

ICD-10 classifications

Multiple myelomaMultiple myeloma and malignant plasma cell neoplasmsOther myeloid leukaemiaMyeloid leukaemiaOther myelodysplastic syndromes

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06296121
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06296121 through Pure Global AI's free database. This Phase 3 trial is sponsored by Biocad and is currently Recruiting. The study focuses on Multiple Myeloma. Target enrollment is 252 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.