Идёт набор NCT05243797

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

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: Teclistamab, Lenalidomide.
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, Аргентина, Австралия, Австрия, Бельгия +20
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4

Обзор

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Вмешательства

Препарат Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Препарат Lenalidomide
Lenalidomide will be administered orally

Первичные конечные точки

Progression Free Survival (PFS) [Срок оценки: from randomization to the date of disease progression or death (approximately up to 8 years)]
Minimal Residual Disease (MRD)-negative Complete Response (CR) [Срок оценки: at month 12]

Вторичные конечные точки (7)

Comparison of efficacy [Срок оценки: from randomization to the date of disease progression or death (approximately up to 8 years)]
Overall Survival (OS) [Срок оценки: from the date of from randomization to the date the subject's death, assessed up to 8 years]]
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms [Срок оценки: baseline up to 8 years]
EQ-5D-5L health utility values and the difference between-treatment arms [Срок оценки: baseline up to 8 years]
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms [Срок оценки: baseline up to 8 years]
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms [Срок оценки: baseline up to week 24]
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms [Срок оценки: baseline up to 8 years]

Критерии участия

Критерии включения

Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
Must not be intolerant to the starting dose of lenalidomide.
Must not have received any maintenance therapy.
Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
Have clinical laboratory values within prespecified range.

Критерии исключения

Received any prior BCMA-directed therapy.
Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
Progressed on multiple myeloma therapy at any time prior to screening.
Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

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