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

NCT07742215 | Recruiting Phase 3 DMC

• 1 other identifier: BCD-248-3/AMMADINA
• Study Type: interventional
• Target: 390
• Locations: 2 countries
• Sites: 16

Brief 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

Keywords

biologics; monoclonal antibodies

Outcome Measures

Primary Outcomes (2)

• Frequency of MRD negativity by flow cytometry at 12 months from the start of therapy

  up to 12 months

• Progression-free survival according to the International Myeloma Working Group (IMWG) criteria

  The disease status and treatment efficacy will be analyzed according to the International Myeloma Working Group (IMWG) criteria for response and minimal residual disease assessment in multiple myeloma proposed in 2006 and modified in 2011 and 2016

  up to 36 months

Secondary Outcomes (14)

• Overall response rate (at least partial response) according to the IMWG criteria.

  up to 5 years

• Frequency of at least a complete response according to the IMWG criteria.

  up to 5 years

• Frequency of at least a very good partial response according to the IMWG criteria.

  up to 5 years

• Frequency of MRD negativity.

  up to 5 years

• Frequency of sustained MRD negativity.

  up to 5 years

Study Arms (2)

BCD-248-Dara

EXPERIMENTAL

BCD-248 in combination with daratumumab

Drug: BCD-248 + daratumumab

DPd

ACTIVE COMPARATOR

Daratumumab in combination with pomalidomide and dexamethasone

Drug: Daratumumab + pomalidomide + dexamethasone

Interventions

BCD-248 + daratumumab DRUG

BCD-248 subcutaneously, daratumumab intravenously

BCD-248-Dara

Daratumumab + pomalidomide + dexamethasone DRUG

Daratumumab intravenously, pomalidomide per os, dexamethasone per os

DPd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Age ≥18 years.
• Documented diagnosis of multiple myeloma according to the IMWG criteria.
• Measurable disease at screening.
• At least 1, but not more than 3 prior lines of antimyeloma therapy, including lenalidomide and a proteasome inhibitor.
• Documented progression according to the IMWG criteria during or after the last line of therapy.
• ECOG score 0-2.
• Resolution of symptoms of toxicity on the prior line of therapy.

You may not qualify if:

• Prior therapy with anti-BCMA or anti-CD3 drugs, pomalidomide.
• Refractory to anti-CD38 monoclonal antibodies according to the IMWG criteria.
• Use of any investigational products or medical devices within 28 days prior to randomization or planned use of investigational products or medical devices during participation in this study.
• Hematopoietic stem cell transplantation - prior to randomization or planned during the study
• Plasmapheresis within 14 days prior to randomization.
• Administration of a live attenuated vaccine within 28 days prior to randomization.
• A history of myelodysplastic syndrome or other malignancies other than multiple myeloma within 5 years prior to screening.
• Life-threatening acute complications of the underlying disease.
• Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:
• Stable angina pectoris, functional class III-IV.
• Unstable angina pectoris and/or myocardial infarction within 6 months prior to randomization.
• Congestive heart failure, NYHA class III-IV.
• Clinically significant (according to the Investigator) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy must be stable for 4 weeks before the planned start of the study therapy).
• Moderate to severe asthma, uncontrolled asthma, asthma with forced expiratory volume in 1 second \<50% of predicted normal.
• Chronic obstructive pulmonary disease with forced expiratory volume in 1 second \<50% of predicted normal.

Sponsors & Collaborators

• Biocad: lead

Study Sites (16)

SI "Republican Scientific and Practical Center for Radiation Medicine and Human Ecology"

Homyel, Belarus

RECRUITING

SBHI "Chelyabinsk regional clinical hospital"

Chelyabinsk, Russia

RECRUITING

SBHI "Regional oncological dispensary"

Irkutsk, Russia

RECRUITING

SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"

Kazan', Russia

RECRUITING

Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"

Krasnoyarsk, Russia

RECRUITING

Branch Office of Hadassah Medical Ltd.

Moscow, Russia

RECRUITING

BHI of the Omsk region "Clinical Oncological Dispensary"

Omsk, Russia

RECRUITING

St. Petersburg State Healthcare Institution "City Hospital No. 15"

Saint Petersburg, 190000, Russia

RECRUITING

FSBI "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

SBHI "Leningrad Regional Clinical Hospital"

Saint Petersburg, Russia

RECRUITING

FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation

Samara, Russia

RECRUITING

FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia

Saratov, Russia

RECRUITING

Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"

Smolensk, Russia

RECRUITING

State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region

Sochi, Russia

RECRUITING

SBHI "Republican Clinical Hospital named G.G. Kuvatov"

Ufa, Russia

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Arina Zinkina

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

Evgeniia Mikhailova

CONTACT

+79110812368; mikhailova@biocad.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); RU (15)