Идёт набор NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

Фаза III 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: JNJ-79635322, Teclistamab.
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, Австралия, Канада, Китай, Франция +9
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

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Обзор

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Вмешательства

Препарат JNJ-79635322
JNJ-79635322 will be administered as SC injection.
Препарат Teclistamab
Teclistamab will be administered as SC injection.

Первичные конечные точки

Overall Response [Срок оценки: Up to 5 years and 7 months]
Progression-Free Survival (PFS) [Срок оценки: Up to 5 years and 7 months]

Вторичные конечные точки (12)

Very Good Partial Response (VGPR) or Better [Срок оценки: Up to 5 years and 7 months]
Complete Response (CR) or Better [Срок оценки: Up to 5 years and 7 months]
Duration of Response (DoR) [Срок оценки: Up to 5 years and 7 months]
Minimal Residual Disease (MRD)-negative CR [Срок оценки: Up to 5 years and 7 months]
MRD-Negative CR at 12 months [Срок оценки: 12 months]
Sustained MRD-negative CR [Срок оценки: Up to 5 years and 7 months]
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) [Срок оценки: Up to 5 years and 7 months]
Overall Survival (OS) [Срок оценки: Up to 5 years and 7 months]
Time to Subsequent Anti-Myeloma Therapy [Срок оценки: Up to 5 years and 7 months]
Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity [Срок оценки: Up to 5 years and 7 months]
Number of Participants with Abnormalities in Clinical Laboratories Results [Срок оценки: Up to 5 years and 7 months]
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score [Срок оценки: Baseline up to 5 years and 7 months]

Критерии участия

Inclusion:

Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:

MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
Measurable disease at screening as assessed by central laboratory
Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria
Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

Active hepatitis of infectious origin
Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
Major surgery, (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
Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Открытое
Основная цель: Лечение