RecruitingPhase 3NCT06296121

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 Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma


Sponsor

Biocad

Enrollment

252 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for multiple myeloma (a blood cancer) that has come back or stopped responding: BCD-264 (a new drug) versus daratumumab (Darzalex), a well-known approved treatment. Both target a protein on myeloma cells called CD38. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of multiple myeloma - Your disease has come back or is no longer responding to treatment - You have previously been treated with both a proteasome inhibitor and an immunomodulatory drug - Your disease is measurable on lab tests - You are generally functional (ECOG score 0–2) - You are willing to have a bone marrow biopsy **You may NOT be eligible if...** - You have previously been treated with daratumumab or any other anti-CD38 therapy - You had a stem cell transplant (your own cells) within the last 12 weeks, or ever had a donor transplant - You have plasma cell leukemia, POEMS syndrome, or amyloidosis - You are pregnant or not willing to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCD-264

IV, 16 mg/kg

DRUGDarzalex

IV, 16 mg/kg


Locations(14)

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, Russia

Kuzbass Regional Clinical Hospital named after S.V. Belyaev

Kemerovo, Russia

Regional Clinical Hospital

Krasnoyarsk, Russia

Moscow City Clinical Hospital 52

Moscow, Russia

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia

Almazov National Medical Research Centre

Saint Petersburg, Russia

N.N. Petrov National Medicine Research Center of oncology

Saint Petersburg, Russia

Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency

Saint Petersburg, Russia

St Petersburg State I.P. Pavlov Medical University

Saint Petersburg, Russia

State budgetary healthcare institution Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Samara State Medical University

Samara, Russia

Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

Sochi, Russia

Bashkir State Medical University

Ufa, Russia

Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, Russia

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NCT06296121


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