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A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)

NCT07742215 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-08-03

No results posted yet for this study

Summary

The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma. The study will be conducted in a population of male and female subjects aged 18 years and older, with confirmed symptomatic multiple myeloma with measurable disease, who have received one prior line of therapy that included a proteasome inhibitor and lenalidomide and were refractory to lenalidomide, or who have received two or three prior lines of therapy that included a proteasome inhibitor and lenalidomide, with disease progression during or after the last line of therapy.

Conditions

  • Myeloma Multiple

Interventions

DRUG

BCD-248 + daratumumab

BCD-248 subcutaneously, daratumumab intravenously

DRUG

Daratumumab + pomalidomide + dexamethasone

Daratumumab intravenously, pomalidomide per os, dexamethasone per os

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina Zinkina · Director of Clinical Development Department, BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-07-31
Completion
2032-10-31

Countries

  • Belarus
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742215 on ClinicalTrials.gov