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Набира участници Фаза 3 NCT06208150

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

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 effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
Кой може да участва
Inclusion Criteria: * Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level \>= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (\>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (\<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment * Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment * 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 Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients * Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF) * Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment * A maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Места на провеждане 25
Argentina (1)
Fundaleu
Buenos Aires
ACTIVE_NOT_RECRUITING
Австралия (1)
Royal Adelaide Hospital
Adelaide
ACTIVE_NOT_RECRUITING
Белгия (1)
Grand Hopital De Charleroi Site Les Viviers
Charleroi
ACTIVE_NOT_RECRUITING
Бразилия (1)
Cetus Oncologia
Belo Horizonte
ACTIVE_NOT_RECRUITING
Канада (1)
Arthur J E Child Comprehensive Cancer Centre
Calgary , Alberta
ACTIVE_NOT_RECRUITING
Китай (1)
Beijing Chaoyang Hospital
Beijing
ACTIVE_NOT_RECRUITING
Чехия (1)
Fakultni nemocnice Brno
Brno-Bohunice
ACTIVE_NOT_RECRUITING
Дания (1)
Aarhus University Hospital
Aarhus
COMPLETED
Франция (1)
Hopital Claude Huriez
Lille
ACTIVE_NOT_RECRUITING
Гърция (1)
251 Airforces Hospital
Athens
ACTIVE_NOT_RECRUITING
Унгария (1)
Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
Budapest
ACTIVE_NOT_RECRUITING
Индия (1)
Fortis Memorial Research Institute
Gurgaon
ACTIVE_NOT_RECRUITING
Израел (1)
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov
ACTIVE_NOT_RECRUITING
Италия (1)
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria
ACTIVE_NOT_RECRUITING
Япония (1)
Juntendo University Hospital
Bunkyō City
ACTIVE_NOT_RECRUITING
Mexico (1)
Centro de Quimioterapia e Investigacion
Guadalajara
ACTIVE_NOT_RECRUITING
Нидерландия (1)
Flevoziekenhuis
Almere Stad
ACTIVE_NOT_RECRUITING
Полша (1)
Wojewodzki Szpital Specjalistyczny
Biała Podlaska
ACTIVE_NOT_RECRUITING
Saudi Arabia (1)
King Abdullah International Medical Research Center (KAIMRC)
Riyadh
COMPLETED
Южна Корея (1)
Dong-A University Hospital
Busan
ACTIVE_NOT_RECRUITING
Испания (1)
Hosp. de Cabuenes
Asturias
ACTIVE_NOT_RECRUITING
Швеция (1)
Skanes universitetssjukhus
Lund
ACTIVE_NOT_RECRUITING
Турция (1)
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara
ACTIVE_NOT_RECRUITING
Великобритания (1)
Blackpool Victoria Hospital
Blackpool
COMPLETED
САЩ (1)
UCSF Fresno
Clovis , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.01.2024
Крайна дата
31.03.2028
Регистрационен номер
NCT06208150
Източник
anzctr
Запитване за медицински туризъм

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