Идёт набор NCT05552222

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed 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: Teclistamab, Daratumumab, Lenalidomide, Dexamethasone.
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, Австрия, Бельгия, Бразилия +20
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 Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Обзор

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Вмешательства

Препарат Teclistamab
Teclistamab will be administered as SC injection.
Препарат Daratumumab
Daratumumab will be administered as SC injection.
Препарат Lenalidomide
Lenalidomide will be administered orally.
Препарат Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
Препарат Talquetamab
Talquetamab will be administered as SC injection.

Первичные конечные точки

Progression Free Survival (PFS) [Срок оценки: From randomization to the date of disease progression or death (Up to 09 years)]
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) [Срок оценки: At Month 12]

Вторичные конечные точки (12)

Very Good Partial Response (VGPR) or Better [Срок оценки: From randomization up to 09 years]
Complete Response (CR) or Better [Срок оценки: From randomization up to 09 years]
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR) [Срок оценки: From randomization up to 09 years]
MRD-negative CR [Срок оценки: From randomization up to 09 years]
Progression Free Survival on Next-line Therapy (PFS2) [Срок оценки: From randomization up to 09 years]
Overall Survival (OS) [Срок оценки: From randomization to the date of death (up to 09 years)]
Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: From randomization up to 09 years]
Number of Participants with Abnormalities in Laboratory Parameters [Срок оценки: From randomization up to 09 years]
Number of Participants with Abnormalities in Vital Signs [Срок оценки: From randomization up to 09 years]
Number of Participants with Abnormalities in Physical Examination [Срок оценки: From randomization up to 09 years]
Number of Participants with Abnormalities in Electrocardiogram (ECG) [Срок оценки: From randomization up to 09 years]
Serum Concentrations of Teclistamab and Talquetamab [Срок оценки: From randomization up to 09 years]

Критерии участия

Критерии включения

Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment

Критерии исключения

Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization
Had plasmapheresis within 28 days of randomization
Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone

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