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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат BCD-248
  subcutaneously

Первичные конечные точки

• Overall response rate according to IMWG (International Myeloma Working Group) criteria [Срок оценки: Up to 24 weeks]

Вторичные конечные точки (12)

• Progression-free survival (PFS) [Срок оценки: Up to 104 weeks]
• Complete response (CR) rate according to IMWG criteria [Срок оценки: Up to 3.7 years]
• MRD (minimal residual disease)-negativity rate [Срок оценки: Up to 3.7 years]
• Duration of response [Срок оценки: Up to 3.7 years]
• Time to progression [Срок оценки: Up to 3.7 years]
• Time to response [Срок оценки: Up to 3.7 years]
• Overall survival [Срок оценки: Up to 3.7 years]
• Incidence and characteristics of adverse events [Срок оценки: Up to 3.7 years]
• Cmax after the first administration [Срок оценки: up to Day 6]
• Cmin after the first administration [Срок оценки: up to Day 6]
• AUC0-t after the first administration [Срок оценки: up to Day 6]
• Ctrough [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 20 центров

• SBHI of the Kaliningrad region "Central City Clinical Hospital" — Kaliningrad
• SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of — Kazan'
• FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Feder — Kirov
• Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospit — Krasnoyarsk
• Branch of the limited liability company "Hadassah Medical LTD" — Moscow
• City Clinical Hospital №52 of the Department of Health of the City of Moscow — Moscow
• FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Minis — Moscow
• JSC "Medsi Group of Companies" — Moscow
• … и ещё 12 центров

Идентификаторы

NCT: NCT06668792 · BCD-248-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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