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Myeloma MultiplePhase 3AMMADINANCT07742215

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

A Phase 3 study testing BCD-248 + daratumumab and Daratumumab + pomalidomide + dexamethasone in people with Myeloma Multiple, run by Biocad at 16 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma Multiple
What is being tested?
BCD-248 + daratumumab and Daratumumab + pomalidomide + dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
16 sitesin 2 countries
Study dates
15 Jun 2026to Oct 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.
  • A history of angioneurotic edema, severe respiratory failure.
  • Active autoimmune diseases. Patients with type 1 diabetes mellitus and hypothyroidism, requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, psoriasis, etc.), which do not require systemic therapy, are allowed to participate.
  • Thromboembolic (deep vein thrombosis, pulmonary embolism) or cerebrovascular (stroke, transient ischemic attack) events within 6 months prior to randomization.
  • Any infection within 14 days prior to randomization that requires systemic etiological therapy or may, in the Investigator's opinion, increase the risk of infectious complications.
  • Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.
  • Subjects with amyloidosis, POEMS syndrome, plasma cell leukemia
  • CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
  • HIV infection, active HBV infection, hepatitis C.
  • Hypersensitivity, allergy, or intolerance to monoclonal antibodies or any component of BCD-248, daratumumab, pomalidomide, or dexamethasone.
  • Major surgery within less than 14 days prior to the expected start of the study therapy, incomplete recovery from surgery, or planned surgery during participation in the study.
  • Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period and within 180 days after receiving the last dose of the IP.

Trial locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Evgeniia Mikhailova contact

+79110812368

mikhailova@biocad.ru

16 sites in 2 countries

Russia15 sites, 15 recruiting

  • SBHI "Chelyabinsk regional clinical hospital"

    Chelyabinsk

    Marina Kiseleva

    Recruiting

  • SBHI "Regional oncological dispensary"

    Irkutsk

    Denis Iukalchuk

    Recruiting

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

    Kazan'

    Gulnara Husainova

    Recruiting

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

    Krasnoyarsk

    Elena Martynova

    Recruiting

  • Branch Office of Hadassah Medical Ltd.

    Moscow

    Vidmantė Daylidite

    Recruiting

  • BHI of the Omsk region "Clinical Oncological Dispensary"

    Omsk

    Anastasia Zimina

    Recruiting

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

    Saint Petersburg, 190000

    Elena Karyagina

    Recruiting

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

    Saint Petersburg

    Yurii Osipov

    Recruiting

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

    Saint Petersburg

    Andrei Garifullin

    Recruiting

  • SBHI "Leningrad Regional Clinical Hospital"

    Saint Petersburg

    Sergei Voloshin

    Recruiting

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

    Samara

    Igor Davidkin

    Recruiting

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

    Saratov

    Tatyana Shelehova

    Recruiting

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

    Smolensk

    Mariia Novikova

    Recruiting

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

    Sochi

    Dmitrii Kirtbaia

    Recruiting

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

    Ufa

    Aigul Latypova

    Recruiting

Other trials in Russia

Belarus1 site, 1 recruiting

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

    Homyel

    Dmitry Novik

    Recruiting

Other trials in Belarus

About this study

Official title: A Phase III Open-Label, Randomized Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab Versus Daratumumab, Pomalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

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.

Being tested
BCD-248 + daratumumab, Daratumumab + pomalidomide + dexamethasone
Keywords
biologics, monoclonal antibodies
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-248 + daratumumabDrug

    BCD-248 subcutaneously, daratumumab intravenously

  • Daratumumab + pomalidomide + dexamethasoneDrug

    Daratumumab intravenously, pomalidomide per os, dexamethasone per os

Study groups in NCT07742215
Study groupRoleWhat they receive
BCD-248-DaraExperimentalBCD-248 in combination with daratumumab
Receives: Drug: BCD-248 + daratumumab
DPdActive comparatorDaratumumab in combination with pomalidomide and dexamethasone
Receives: Drug: Daratumumab + pomalidomide + dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 12 months

  2. 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

    Measured: up to 36 months

Secondary outcomes (14)

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

    Measured: up to 5 years

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

    Measured: up to 5 years

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

    Measured: up to 5 years

  4. Frequency of MRD negativity.

    Measured: up to 5 years

  5. Frequency of sustained MRD negativity.

    Measured: up to 5 years

  6. Time to response.

    Measured: up to 5 years

  7. Duration of response.

    Measured: up to 5 years

  8. Time to progression.

    Measured: up to 5 years

  9. Overall survival.

    Measured: up to 5 years

  10. Ctrough of BCD-248.

    Pharmacokinetics

    Measured: up to 12 months

  11. Changes over time in the concentration of soluble BCMA in the blood.

    Pharmacodynamics

    Measured: up to 12 months

  12. Changes over time in lymphocyte populations.

    Pharmacodynamics

    Measured: up to 12 months

  13. Proportion of participants with detected BAbs and NAbs to BCD-248

    Immunogenicity

    Measured: up to 5 years

  14. Incidence and characteristics of adverse events

    ITo assess the safety of the study therapy, vital signs will be assessed, physical, laboratory and instrumental examinations will be performed, and the presence and characteristics of adverse events will be assessed

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start15 Jun 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionOct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742215
Sponsor's protocol ID
BCD-248-3/AMMADINA
Acronym
AMMADINA
Status last verified
Jul 2026
First submitted
23 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-248 + daratumumab and Daratumumab + pomalidomide + dexamethasone in people with Myeloma Multiple, run by Biocad at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evgeniia Mikhailova (+79110812368, mikhailova@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of MRD negativity by flow cytometry at 12 months from the start of therapy (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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