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

Спонсор: European Myeloma Network B.V.

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Места на провеждане 22
Argentina (1)
Hospital Italiano
Buenos Aires
Австралия (1)
Sunshine Coast Health
Birtinya , Queensland
Белгия (1)
Jessa Ziekenhuis
Hasselt
Бразилия (1)
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre
Канада (1)
Cross Cancer Institute
Edmonton
Китай (1)
Beijing Chaoyang Hospital
Beijing
Чехия (1)
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Дания (1)
Aarhus Universitetshospital
Aarhus
Франция (1)
Centre Hospitalier Universitaire De Bordeaux
Bordeaux
Гърция (1)
University General Hospital Of Alexandroupoli
Alexandroupoli
Ireland (1)
Cork University Hospital
Cork
Израел (1)
The Barzilai Medical Center
Beersheba
Италия (1)
Azienda Sanitaria Locale Al Di Alessandria
Alessandria
Нидерландия (1)
Noordwest Ziekenhuisgroep Stichting
Alkmaar
Норвегия (1)
St. Olavs hospital HF
Trondheim
Полша (1)
Department of Hematology and Transplantology University Clinical Center
Gdansk
ACTIVE_NOT_RECRUITING
Сърбия (1)
University Clinical Center of Serbia
Belgrade
Южна Корея (1)
Chonnam National University Hwasun Hospital
Gwangju
Швейцария (1)
University Hospital Basel
Basel
Турция (1)
Ankara Liv Hospital
Ankara
Великобритания (1)
Hammersmith Hospital - Imperial College NHS Healthcare Trust
London
САЩ (1)
Banner University Medical Center Tucson, University of Arizona
Phoenix , Arizona
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
08.09.2022
Крайна дата
01.04.2032
Регистрационен номер
NCT05243797
Източник
anzctr
Запитване за медицински туризъм

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