A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma (TRI Pro)
27 августа 2026 г. обновлено: Janssen Research & Development, LLC
79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo.
CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
230
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Study Contact
- Номер телефона: 844-434-4210
- Электронная почта: Participate-In-This-Study1@its.jnj.com
Места учебы
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Concord, Австралия, 2139
- Рекрутинг
- Concord Repatriation General Hospital
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Buenos Aires, Аргентина, C1426ANZ
- Рекрутинг
- Instituto Alexander Fleming
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Buenos Aires, Аргентина, C1118
- Рекрутинг
- Hospital Aleman
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Córdoba, Аргентина, X5016KEH
- Рекрутинг
- Hospital Privado Centro Medico de Cordoba
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Ampang, Малайзия, 68000
- Рекрутинг
- Hospital Ampang
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Johor Bharu, Малайзия, 80100
- Рекрутинг
- Hospital Sultanah Aminah
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Kota Kinabalu, Малайзия, 88586
- Рекрутинг
- Hospital Queen Elizabeth
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Kuching, Малайзия, 93586
- Рекрутинг
- Sarawak General Hospital
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California
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Beverly Hills, California, Соединенные Штаты, 90211
- Рекрутинг
- Beverly Hills Cancer Center (BHCC)
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion criteria:
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol
- Received at least 1 prior lines of antimyeloma therapy
- Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response (that is, partial response or better) or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy
- Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria:
- Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
- Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
- Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM that is considered at high risk of recurrence requiring systemic therapy
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Arm A: Tocilizumab + Ramantamig
Participants will receive tocilizumab alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
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Ramantamig will be administered as subcutaneous (SC) injection.
Другие имена:
Tocilizumab will be administered as intravenous (IV) injection.
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Плацебо Компаратор: Arm B: Placebo + Ramantamig
Participants will receive placebo (saline) alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).
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Ramantamig will be administered as subcutaneous (SC) injection.
Другие имена:
Placebo (saline) will be administered as IV injection.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Alive and Free of Treatment-Emergent American Society for Transplantation and Cellular Therapy (ASTCT) Grade Greater Than or Equal to (>=) 2 Cytokine Release Syndrome (CRS)
Временное ограничение: End of Day 28 from ramantamig dose
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Percentage of participants alive and free of treatment-emergent ASTCT Grade >=2 CRS without the use of intervening treatment for CRS of any grade by the end of Day 28 from ramantamig dose will be reported.
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End of Day 28 from ramantamig dose
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from Ramantamig Dose
Временное ограничение: End of Day 28 from ramantamig dose
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Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the end of Day 28 from the ramantamig dose, respectively, will be reported.
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End of Day 28 from ramantamig dose
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Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
Временное ограничение: Up to 37 months
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Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
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Up to 37 months
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Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
Временное ограничение: Up to approximately 3 years and 6 months
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Percentage of participants with re-occurrence of CRS with ASTCT Grade >=2 after the initial occurrence of treatment-emergent Grade >=2 CRS event will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Re-occurrence of CRS for All Grades
Временное ограничение: Up to approximately 3 years and 6 months
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Percentage of participants with re-occurrence of CRS for all Grades will be reported.
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Up to approximately 3 years and 6 months
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Overall Response Rate (ORR)
Временное ограничение: Up to approximately 3 years and 6 months
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ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to progressive disease (PD) or subsequent antimyeloma therapy, in accordance with the international myeloma working group (IMWG) criteria.
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Up to approximately 3 years and 6 months
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Complete Response (CR) or Better
Временное ограничение: Up to approximately 3 years and 6 months
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CR or better rate is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
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Up to approximately 3 years and 6 months
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Very Good Partial Response (VGPR) or Better
Временное ограничение: Up to approximately 3 years and 6 months
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VGPR or better rate is defined as the percentage of participants achieving VGPR, CR or sCR prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
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Up to approximately 3 years and 6 months
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Duration of Response (DoR)
Временное ограничение: Up to approximately 3 years and 6 months
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DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD according to the IMWG response criteria or death due to any cause, whichever occurs first.
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Up to approximately 3 years and 6 months
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Time to Response (TTR)
Временное ограничение: Up to approximately 3 years and 6 months
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TTR is defined as the time from the date of randomization to the date of first documentation of a confirmed response (PR or better) for participants who have PR or better as their best response.
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Up to approximately 3 years and 6 months
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Progression-Free Survival (PFS)
Временное ограничение: Up to approximately 3 years and 6 months
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PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first.
Disease progression will be determined according to the IMWG response criteria.
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Up to approximately 3 years and 6 months
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Time To Next Line of Therapy (TTNT)
Временное ограничение: Up to approximately 3 years and 6 months
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TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.
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Up to approximately 3 years and 6 months
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Time to the First Treatment-emergent Infection with Toxicity Grade >=3
Временное ограничение: Up to approximately 3 years and 6 months
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Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
Временное ограничение: Up to approximately 3 years and 6 months
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Percentage of participants with primary IgRT prophylaxis use will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
Временное ограничение: Up to approximately 3 years and 6 months
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Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Временное ограничение: Up to approximately 3 years and 6 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent antimyeloma therapy, whichever is earlier, or any follow-up AE (linked to an existing TEAE) with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy, or any AE that is considered treatment-related regardless of the start date of the event, is considered to be treatment-emergent.
TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0.
Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Abnormalities in Laboratory Parameters
Временное ограничение: Up to approximately 3 years and 6 months
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Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Incidence of Adverse Events of Clinical Interests
Временное ограничение: Up to approximately 3 years and 6 months
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Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
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Up to approximately 3 years and 6 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
30 июня 2026 г.
Первичное завершение (Оцененный)
31 декабря 2027 г.
Завершение исследования (Оцененный)
8 ноября 2030 г.
Даты регистрации исследования
Первый отправленный
11 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
11 мая 2026 г.
Первый опубликованный (Действительный)
15 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
28 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Новообразования
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Гематологические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Новообразования, Плазматические клетки
- Нарушения гемостаза
- Парапротеинемии
- Нарушения белков крови
- Геморрагические расстройства
- Гемики и лимфатические заболевания
- Множественная миелома
- Tocelizumab
Другие идентификационные номера исследования
- 79635322MMY2002 (Другой идентификатор: Janssen Research & Development, LLC)
- 2025 (Грант/контракт NIH США: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524793-42 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .