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Набира участници Фаза 3 NCT05519085

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Relapsed or Refractory Multiple Myeloma

Спонсор: Celgene

Налично на: БГ
Обобщение
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Кой може да участва
Inclusion Criteria \- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:. i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or. ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP). iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio. * Participants received 1 to 3 prior lines of antimyeloma therapy. * Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy. Exclusion Criteria \- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:. i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded. ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded. * For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity. * Participant has had prior treatment with mezigdomide or pomalidomide. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 27
Argentina (1)
Local Institution - 0318
Chivilcoy , Buenos Aires
ACTIVE_NOT_RECRUITING
Австралия (1)
Local Institution - 0055
Liverpool , New South Wales
ACTIVE_NOT_RECRUITING
Белгия (1)
Ziekenhuis Oost-Limburg, Campus St.-Jan
Genk , Limburg
Natalie Put, Site 0138
Бразилия (1)
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador , Estado de Bahia
EDVAN CRUSOE, Site 0046
Канада (1)
Local Institution - 0225
Greenfield Park , Quebec
ACTIVE_NOT_RECRUITING
Chile (1)
Local Institution - 0329
Santiago , Santiago Metropolitan
ACTIVE_NOT_RECRUITING
Китай (1)
Local Institution - 0062
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
Чехия (1)
Fakultní nemocnice Brno Bohunice
Brno , Brno-město
Финландия (1)
Kuopion Yliopistollinen Sairaala
Kuopio , Northern Savonia
Anu Partanen, Site 0256
Франция (1)
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg , Alsace
Cécile SONNTAG, Site 0175
Германия (1)
TUM Klinikum
München , Bavaria
Marion Hoegner, Site 0392
Гърция (1)
Evangelismos General Hospital of Athens
Athens , Attikí
Sosana Delimpasi, Site 0190
Индия (1)
HCG Aastha Cancer Centre
Ahmedabad , Gujarat
Abhishek Dudhatra, Site 0342
Ireland (1)
University College Hospital - Galway
Galway , Connacht
Janusz Krawczyk, Site 0121
Израел (1)
Meir Medical Center
Kfar Saba , Central District
Osnat Jarchowsky Dolberg, Site 0196
Италия (1)
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola , Emilia-Romagna
DAVIDE NAPPI, Site 0384
Япония (1)
National Cancer Center Hospital East
Kashiwa , Chiba
Junichiro Yuda, Site 0281
New Zealand (1)
Local Institution - 0335
Tauranga , Bay of Plenty
ACTIVE_NOT_RECRUITING
Полша (1)
Local Institution - 0346
Skórzewo , Greater Poland Voivodeship
WITHDRAWN
Puerto Rico (1)
Local Institution - 0355
San Juan
WITHDRAWN
Румъния (1)
Fundeni Clinical Institute
Bucharest
Sorina Badelita, Site 0021
South Africa (1)
Netcare Pretoria East Hospital
Centurion , GP
LUCILLE SINGH, Site 0405
Южна Корея (1)
Local Institution - 0106
Busan , Busan
WITHDRAWN
Испания (1)
Local Institution - 0183
Palma , Balearic Islands
WITHDRAWN
Турция (1)
Ankara University Health Practice and Research Hospitals
Ankara
Guldane Cengiz Seval, Site 0232
Великобритания (1)
Addenbrooke's Hospital
Cambridge , Cambridgeshire
Marquita Camilleri, Site 0326
САЩ (1)
Cancer and Blood Specialty Clinic
Los Alamitos , California
Vu Phan, Site 0366
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.09.2022
Крайна дата
30.11.2033
Регистрационен номер
NCT05519085
Източник
anzctr
Запитване за медицински туризъм

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