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A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma - Trial NCT06296121

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.

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NCT06296121
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06296121
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A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalexยฎ in Subjects With Relapsed and Refractory Multiple Myeloma

Study Focus

Multiple Myeloma

BCD-264

Interventional

drug

Sponsor & Location

Biocad

Chelyabinsk,Ekaterinburg,Kemerovo,Krasnoyarsk,Moscow,Moscow,Saint Petersburg,Saint Petersburg,Saint Petersburg,Saint Petersburg,Saint Petersburg,Samara,Sochi,Ufa, Russian Federation

Timeline & Enrollment

Phase 3

Dec 21, 2023

Jul 01, 2026

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 myeloma
Multiple myeloma and malignant plasma cell neoplasms
Other myeloid leukaemia
Myeloid leukaemia
Other myelodysplastic syndromes

Data Source

ClinicalTrials.gov

NCT06296121

Non-Device Trial