Идёт набор NCT07589634

A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Фаза II С лечением Multiple Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ramantamig, Tocilizumab, Placebo.
Кому может быть актуально: Состояния в реестре: Multiple Myeloma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Малайзия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Препарат Ramantamig
Ramantamig will be administered as subcutaneous (SC) injection.
Препарат Tocilizumab
Tocilizumab will be administered as intravenous (IV) injection.
Препарат Placebo
Placebo (saline) will be administered as IV injection.

Первичные конечные точки

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) [Срок оценки: End of Day 28 from ramantamig dose]

Вторичные конечные точки (12)

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 [Срок оценки: End of Day 28 from ramantamig dose]
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment [Срок оценки: Up to 37 months]
Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event [Срок оценки: Up to approximately 3 years and 6 months]
Percentage of Participants with Re-occurrence of CRS for All Grades [Срок оценки: Up to approximately 3 years and 6 months]
Overall Response Rate (ORR) [Срок оценки: Up to approximately 3 years and 6 months]
Complete Response (CR) or Better [Срок оценки: Up to approximately 3 years and 6 months]
Very Good Partial Response (VGPR) or Better [Срок оценки: Up to approximately 3 years and 6 months]
Duration of Response (DoR) [Срок оценки: Up to approximately 3 years and 6 months]
Time to Response (TTR) [Срок оценки: Up to approximately 3 years and 6 months]
Progression-Free Survival (PFS) [Срок оценки: Up to approximately 3 years and 6 months]
Time To Next Line of Therapy (TTNT) [Срок оценки: Up to approximately 3 years and 6 months]
Time to the First Treatment-emergent Infection with Toxicity Grade >=3 [Срок оценки: Up to approximately 3 years and 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

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

Здоровые добровольцы: Нет