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Can a new drug combo outsmart resistant myeloma?

NCT ID NCT07742215

Disease control Sponsor: Biocad Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This phase III trial is investigating whether adding an experimental drug called BCD-248 to daratumumab can improve outcomes for people with multiple myeloma that has returned or become resistant to treatment. The study will compare this new combination against the current standard of daratumumab, pomalidomide, and dexamethasone. Participants are adults with confirmed multiple myeloma who have had one to three prior lines of therapy. The main goals are to see if the new combo increases the chance of achieving a deep remission and extends the time before the disease progresses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BCD-248 combined with daratumumab
What this could lead to
If successful, this combination could offer a new, more effective treatment option for people with multiple myeloma that has returned or stopped responding to prior therapies.
What could go wrong
This is an early-stage comparison, and the new combination may not prove better than the existing regimen. Side effects are possible, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. Stable angina pectoris, functional class III-IV. 2. Unstable angina pectoris and/or myocardial infarction within 6 months prior to randomization. 3. Congestive heart failure, NYHA class III-IV. 4. 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). 5. Moderate to severe asthma, uncontrolled asthma, asthma with forced expiratory volume in 1 second \<50% of predicted normal. 6. Chronic obstructive pulmonary disease with forced expiratory volume in 1 second \<50% of predicted normal. 7. A history of angioneurotic edema, severe respiratory failure. 8. 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. 9. Thromboembolic (deep vein thrombosis, pulmonary embolism) or cerebrovascular (stroke, transient ischemic attack) events within 6 months prior to randomization. 10. 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. 11. 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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloma multiple

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BHI of the Omsk region "Clinical Oncological Dispensary"

    RECRUITING

    Omsk, Russia

  • Branch Office of Hadassah Medical Ltd.

    RECRUITING

    Moscow, Russia

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

    RECRUITING

    Saratov, Russia

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

    RECRUITING

    Samara, Russia

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

    RECRUITING

    Saint Petersburg, Russia

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

    RECRUITING

    Saint Petersburg, Russia

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

    RECRUITING

    Smolensk, Russia

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

    RECRUITING

    Krasnoyarsk, Russia

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

    RECRUITING

    Kazan', Russia

  • SBHI "Chelyabinsk regional clinical hospital"

    RECRUITING

    Chelyabinsk, Russia

  • SBHI "Leningrad Regional Clinical Hospital"

    RECRUITING

    Saint Petersburg, Russia

  • SBHI "Regional oncological dispensary"

    RECRUITING

    Irkutsk, Russia

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

    RECRUITING

    Ufa, Russia

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

    RECRUITING

    Homyel, Belarus

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

    RECRUITING

    Saint Petersburg, 190000, Russia

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

    RECRUITING

    Sochi, Russia

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