Език: EN EN
← Назад към резултатите
Набира участници Фаза 1 NCT05927571

A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Relapsed or Refractory Multiple Myeloma

Спонсор: Genentech, Inc.

Налично на: БГ
Обобщение
The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.
Кой може да участва
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Diagnosis of R/R MM per IMWG criteria * For female participants of childbearing potential: agreement to remain abstinent or use contraception * For male participants: agreement to remain abstinent or use a condom Exclusion Criteria: * Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5) * Prior treatment with elranatamab * Prior allogeneic stem cell transplantation (SCT) * Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells * Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome * Participants with known history of amyloidosis * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * Peripheral motor polyneuropathy of prespecified grade * Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection * Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Human immunodeficiency virus (HIV) seropositivity * History of central nervous system (CNS) myeloma disease * Significant cardiovascular disease
Места на провеждане 3
Австралия (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Израел (1)
Rambam Health Care Campus
Haifa
Южна Корея (1)
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.08.2023
Крайна дата
31.07.2027
Регистрационен номер
NCT05927571
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.