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

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Drug: BCD-248

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Daria Liaptseva; Phone Number: +79816982050; Email: liaptseva@biocad.ru

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation
    • Not yet recruiting
    • State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"
    • Contact: Tatiana Konstantinova
  • Kaliningrad, Russian Federation
    • Not yet recruiting
    • SBHI of the Kaliningrad region "Central City Clinical Hospital"
    • Contact: Alina Chuprakova
  • Kazan, Russian Federation
    • Not yet recruiting
    • SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"
    • Contact: Gulnara Husainova
  • Kirov, Russian Federation
    • Not yet recruiting
    • FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"
    • Contact: Svetlana Samarina
  • Krasnoyarsk, Russian Federation
    • Recruiting
    • Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
    • Contact: Elena Martynova
  • Moscow, Russian Federation
    • Recruiting
    • Branch of the limited liability company "Hadassah Medical LTD"
    • Contact: Igor Utiashev
  • Moscow, Russian Federation
    • Recruiting
    • City Clinical Hospital №52 of the Department of Health of the City of Moscow
    • Contact: Elena Misiurina
  • Moscow, Russian Federation
    • Not yet recruiting
    • FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
    • Contact: Gaiane Tumian
  • Moscow, Russian Federation
    • Recruiting
    • JSC "MEDSI Group of Companies"
    • Contact: Anastasia Mochalova
  • Moscow, Russian Federation
    • Not yet 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
    • Contact: Vadim Doronin
  • Moscow, Russian Federation
    • Not yet recruiting
    • State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"
    • Contact: Tatiana Mitina
  • Obninsk, Russian Federation
    • Not yet recruiting
    • Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
    • Contact: Natalia Falaleeva
  • Petrozavodsk, Russian Federation
    • Not yet recruiting
    • SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
    • Contact: Aleksandr Miasnikov
  • Saint Petersburg, Russian Federation
    • Recruiting
    • FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation
    • Contact: Yurii Osipov
  • Samara, Russian Federation
    • Not yet recruiting
    • FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
    • Contact: Igor Davidkin
  • Saratov, Russian Federation
    • Recruiting
    • FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
    • Contact: Tatiana Shelekhova
  • Smolensk, Russian Federation
    • Not yet recruiting
    • Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk"
    • Contact: Mariia Novikova
  • Sochi, Russian Federation
    • Not yet recruiting
    • State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region
    • Contact: Dmitrii Kirtbaia
  • Syktyvkar, Russian Federation
    • Recruiting
    • Public institution "Komi Republican cancer clinic"
    • Contact: Andrei Proidakov
  • Ufa, Russian Federation
    • Not yet recruiting
    • FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
    • Contact: Bulat Bakirov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent form.
2. Age ≥18 years.
3. Documented diagnosis of multiple myeloma according to the IMWG criteria.
4. Measurable disease at screening.
5. Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.
6. Documented progression according to the IMWG criteria during or after the last line of therapy.
7. Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.
8. ECOG score 0-2.

Exclusion Criteria:

1. Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
2. 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.
3. 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.
4. Planned hematopoietic stem cell transplantation before disease progression during this study.
5. 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.

6. Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:

   • 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.
7. Subjects with amyloidosis.
8. Clinical signs of meningeal involvement of multiple myeloma.
9. HIV infection, active HBV infection, hepatitis C.
10. 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.
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCD-248	Drug: BCD-248; subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate according to IMWG (International Myeloma Working Group) criteria	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	Up to 104 weeks
Complete response (CR) rate according to IMWG criteria	Up to 3.7 years
MRD (minimal residual disease)-negativity rate	Up to 3.7 years
Duration of response	Up to 3.7 years
Time to progression	Up to 3.7 years
Time to response	Up to 3.7 years
Overall survival	Up to 3.7 years
Incidence and characteristics of adverse events	Up to 3.7 years
Cmax after the first administration	up to Day 6
Cmin after the first administration	up to Day 6
AUC0-t after the first administration	up to Day 6
Ctrough	up to 6 months
Soluble BCMA concentration in the blood	Up to 6 months
Proportion of subjects with BAbs	Up to 3 years
Proportion of subjects with NAbs	Up to 3 years

Collaborators and Investigators

• Sponsor: Biocad

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: BCD-248-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No