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Relapsed/Refractory Multiple MyelomaPhase 2FLAMMINGONCT06668792

An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing BCD-248 in people with Relapsed/Refractory Multiple Myeloma, run by Biocad at 20 sites in Russia.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and/or refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
BCD-248
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
20 sitesRussia
Study dates
26 Dec 2024to Jul 2028
Phase
Phase 2
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.
  • Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.
  • Documented progression according to the IMWG criteria during or after the last line of therapy.
  • Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.
  • ECOG score 0-2.

Who cannot join

  • Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
  • Use of any investigational medicinal products or medical devices within 30 days or 5 half-lives (whichever is longer) prior to the expected start of the study therapy or planned use of investigational medicinal products or medical devices during participation in this study, except for the use described in this Protocol.
  • Autologous hematopoietic stem cell transplantation within 12 weeks prior to the expected start of the study therapy or a history of allogenic stem cell transplantation, regardless of when it was performed.
  • Planned hematopoietic stem cell transplantation before disease progression during this study.
  • A history of other malignancies within 5 years before screening, excluding squamous and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other malignancies, which, in the opinion of the Investigator, have been adequately treated and have a minimal risk of recurrence within 5 years.
  • Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:
Show all 19Show fewer
  • Stable angina pectoris, functional class III-IV.
  • Unstable angina and/or myocardial infarction within less than 6 months before the expected start of the study therapy.
  • Chronic heart failure, NYHA class III-IV;
  • Clinically significant (in the Investigator's opinion) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the expected start of the study therapy);
  • Moderate to severe asthma, grade III-IV chronic obstructive pulmonary disease, a history of angioedema, severe respiratory failure;
  • Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy are eligible);
  • Any infection within 14 days prior to the expected start of the study therapy, requiring systemic etiotropic therapy or which, in the opinion of the Investigator, may 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.
  • Clinical signs of meningeal involvement of multiple myeloma.
  • HIV infection, active HBV infection, hepatitis C.
  • 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

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daria Liaptseva contact

+79816982050

liaptseva@biocad.ru

20 sites in 1 country

Russia20 sites, 20 recruiting

  • SBHI of the Kaliningrad region "Central City Clinical Hospital"

    Kaliningrad

    Alina Chuprakova

    Not yet recruiting

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

    Kazan'

    Gulnara Husainova

    Not yet recruiting

  • FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"

    Kirov

    Svetlana Samarina

    Not yet recruiting

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

    Krasnoyarsk

    Elena Martynova

    Recruiting

  • Branch of the limited liability company "Hadassah Medical LTD"

    Moscow

    Igor Utiashev

    Recruiting

  • City Clinical Hospital №52 of the Department of Health of the City of Moscow

    Moscow

    Elena Misiurina

    Recruiting

  • FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation

    Moscow

    Gaiane Tumian

    Not yet recruiting

  • JSC "Medsi Group of Companies"

    Moscow

    Anastasia Mochalova

    Recruiting

  • SBI of health care of the city of Moscow city clinical hospital named after S. P. Botkin of the Department of health of the City of Moscow

    Moscow

    Vadim Doronin

    Not yet recruiting

  • State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"

    Moscow

    Tatiana Mitina

    Not yet recruiting

  • Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

    Obninsk

    Natalia Falaleeva

    Not yet recruiting

  • SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"

    Petrozavodsk

    Aleksandr Miasnikov

    Not yet recruiting

  • FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation

    Saint Petersburg

    Yurii Osipov

    Recruiting

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

    Samara

    Igor Davidkin

    Not yet recruiting

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

    Saratov

    Tatiana Shelekhova

    Recruiting

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

    Smolensk

    Mariia Novikova

    Not yet recruiting

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

    Sochi

    Dmitrii Kirtbaia

    Not yet recruiting

  • Public institution "Komi Republican cancer clinic"

    Syktyvkar

    Andrei Proidakov

    Recruiting

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

    Ufa

    Bulat Bakirov

    Not yet recruiting

  • State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"

    Yekaterinburg

    Tatiana Konstantinova

    Not yet recruiting

Other trials in Russia

About this study

Official title: An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed/Refractory Multiple Myeloma

The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and/or refractory multiple myeloma.

Being tested
BCD-248
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-248Drug

    subcutaneously

Study groups in NCT06668792
Study groupRoleWhat they receive
BCD-248ExperimentalNot described
Receives: Drug: BCD-248

What is being measured

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

  1. Overall response rate according to IMWG (International Myeloma Working Group) criteria

    Measured: Up to 24 weeks

Secondary outcomes (15)

  1. Progression-free survival (PFS)

    Measured: Up to 104 weeks

  2. Complete response (CR) rate according to IMWG criteria

    Measured: Up to 3.7 years

  3. MRD (minimal residual disease)-negativity rate

    Measured: Up to 3.7 years

  4. Duration of response

    Measured: Up to 3.7 years

  5. Time to progression

    Measured: Up to 3.7 years

  6. Time to response

    Measured: Up to 3.7 years

  7. Overall survival

    Measured: Up to 3.7 years

  8. Incidence and characteristics of adverse events

    Measured: Up to 3.7 years

  9. Cmax after the first administration

    Measured: up to Day 6

  10. Cmin after the first administration

    Measured: up to Day 6

  11. AUC0-t after the first administration

    Measured: up to Day 6

  12. Ctrough

    Measured: up to 6 months

  13. Soluble BCMA concentration in the blood

    Measured: Up to 6 months

  14. Proportion of subjects with BAbs

    Measured: Up to 3 years

  15. Proportion of subjects with NAbs

    Measured: Up to 3 years

Timeline

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

  1. First posted31 Oct 2024
  2. Study start26 Dec 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJul 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668792
Sponsor's protocol ID
BCD-248-2
Acronym
FLAMMINGO
Status last verified
Feb 2025
First submitted
30 Oct 2024
Last updated
4 Feb 2025
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 2 study testing BCD-248 in people with Relapsed/Refractory Multiple Myeloma, run by Biocad at 20 sites in Russia.

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 19 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Daria Liaptseva (+79816982050, liaptseva@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate according to IMWG (International Myeloma Working Group) criteria (time frame: Up to 24 weeks). 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 NCT06668792.

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 4 Feb 2025.

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