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Набира участници Фаза 3 NCT06932562

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Фаза 3 – широко изпитване преди одобрение
Заболявания: Multiple Myeloma

Спонсор: European Myeloma Network B.V.

Налично на: БГ
Обобщение
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
Кой може да участва
Inclusion Criteria: 1. Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria. 2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol. 3. Participants must have measurable disease as defined in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. Participants must have clinical laboratory values within a prespecified range. Exclusion Criteria: 1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone. 2. Participants who defer transplant due to personal preference. 3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome. 4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of: * focal radiation and/or * a short course of corticosteroids as defined in the protocol. 5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM 6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1. 7. Participants who have uncontrolled intercurrent illness. 8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information. 9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time. NOTE Other protocol defined inclusion/exclusion criteria apply.
Места на провеждане 15
Австралия (1)
Flinders Medical Centre
Adelaide
Хърватия (1)
University Hospital Centre Zagreb - Clinic for Internal Medicine
Zagreb
Чехия (1)
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Дания (1)
Aarhus Universitetshospital
Aarhus
Estonia (1)
North Estonia Medical Centre Foundation
Tallinn
Финландия (1)
Helsinki University Hospital Comprehensive Cancer Center
Helsinki
Гърция (1)
University Hospital of Alexandroupolis
Alexandroupoli
Ireland (1)
Cork University Hospital
Cork
Италия (1)
AOU Ospedali Riuniti di Ancona
Ancona
Нидерландия (1)
Erasmus MC
Rotterdam
Норвегия (1)
Stavanger University Hospital
Stavanger
Португалия (1)
CHUC
Coimbra
Испания (1)
Institut Catala D'oncologia (Badalona)
Badalona
Швеция (1)
Skåne University Hospital, Region Skåne
Lund
Турция (1)
Ankara University Faculty of Medicine, Department of Hematology
Ankara
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.12.2025
Крайна дата
01.12.2036
Регистрационен номер
NCT06932562
Източник
anzctr
Запитване за медицински туризъм

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