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Набира участници Фаза 3 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 3 – широко изпитване преди одобрение
Заболявания: Multiple Myeloma

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
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).
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Места на провеждане 21
Австралия (1)
Royal Prince Alfred Hospital
Camperdown
Белгия (1)
Institut Jules Bordet
Anderlecht
Бразилия (1)
Fundacao Pio XII
Barretos
Канада (1)
Arthur J E Child Comprehensive Cancer Centre
Calgary , Alberta
Китай (1)
Peking Union Medical College Hospital
Beijing
Чехия (1)
Fakultni nemocnice Brno
Brno-Bohunice
Дания (1)
Aalborg University Hospital
Aalborg
Франция (1)
CHU Henri Mondor
Créteil
Гърция (1)
Alexandra General Hospital of Athens
Athens Attica
Израел (1)
Soroka Medical Center
Beersheba
Италия (1)
ASST Papa Giovanni XXIII Bergamo
Bergamo
Япония (1)
Juntendo University Hospital
Bunkyō City
Нидерландия (1)
VUMC Amsterdam
Amsterdam
Норвегия (1)
Oslo University Hospital HF Ulleval sykehus
Oslo
Полша (1)
Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
Biała Podlaska
COMPLETED
Южна Корея (1)
Dong-A University Hospital
Busan
Испания (1)
Hosp. Univ. Germans Trias I Pujol
Badalona
Швеция (1)
Falu Lasarett
Falun
Турция (1)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
Великобритания (1)
University Hospitals Birmingham NHS Foundation Trust
Birmingham
САЩ (1)
Banner MD Anderson Cancer Center
Gilbert , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
25.10.2022
Крайна дата
28.10.2033
Регистрационен номер
NCT05552222
Източник
anzctr
Запитване за медицински туризъм

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