An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients with Relapsed/Refractory Multiple Myeloma
- Registration Number
- NCT06668792
- Lead Sponsor
- Biocad
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
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Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
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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.
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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.
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Planned hematopoietic stem cell transplantation before disease progression during this study.
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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.
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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.
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Subjects with amyloidosis.
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Clinical signs of meningeal involvement of multiple myeloma.
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HIV infection, active HBV infection, hepatitis C.
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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.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BCD-248 BCD-248 -
- Primary Outcome Measures
Name Time Method Overall response rate according to IMWG (International Myeloma Working Group) criteria Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Proportion of subjects with BAbs Up to 3 years Proportion of subjects with NAbs Up to 3 years 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
Trial Locations
- Locations (20)
State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"
🇷🇺Ekaterinburg, Russian Federation
SBHI of the Kaliningrad region "Central City Clinical Hospital"
🇷🇺Kaliningrad, Russian Federation
SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"
🇷🇺Kazan, Russian Federation
FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"
🇷🇺Kirov, Russian Federation
Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
🇷🇺Krasnoyarsk, Russian Federation
Branch of the limited liability company "Hadassah Medical LTD"
🇷🇺Moscow, Russian Federation
City Clinical Hospital №52 of the Department of Health of the City of Moscow
🇷🇺Moscow, Russian Federation
FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
🇷🇺Moscow, Russian Federation
JSC "Medsi Group of Companies"
🇷🇺Moscow, Russian Federation
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, Russian Federation
State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"
🇷🇺Moscow, Russian Federation
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
🇷🇺Obninsk, Russian Federation
SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
🇷🇺Petrozavodsk, Russian Federation
FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation
FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
🇷🇺Samara, Russian Federation
FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
🇷🇺Saratov, Russian Federation
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"
🇷🇺Smolensk, Russian Federation
State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region
🇷🇺Sochi, Russian Federation
Public institution "Komi Republican cancer clinic"
🇷🇺Syktyvkar, Russian Federation
FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
🇷🇺Ufa, Russian Federation