Идёт набор NCT07518186
A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: JNJ-79635322, Teclistamab.
- Кому может быть актуально
- Состояния в реестре: Multiple Myeloma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австралия, Китай, Франция, Германия +10
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide
Обзор
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Вмешательства
- Препарат JNJ-79635322
JNJ-79635322 will be administered as SC injection. - Препарат Teclistamab
Teclistamab will be administered as SC injection.
Первичные конечные точки
- Complete Response (CR) or Better [Срок оценки: Up to approximately 41 months]
- Progression-Free Survival (PFS) [Срок оценки: Up to approximately 41 months]
Вторичные конечные точки (12)
- Overall Response Rate (ORR) [Срок оценки: Up to approximately 41 months]
- Very Good Partial Response (VGPR) or Better [Срок оценки: Up to approximately 41 months]
- Duration of Response (DoR) [Срок оценки: Up to approximately 41 months]
- Minimal Residual Disease (MRD)-negative CR [Срок оценки: Up to approximately 41 months]
- MRD-negative CR at 1 Year [Срок оценки: At 1 Year]
- MRD-negative CR at 5 Years [Срок оценки: At 5 Years]
- Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) [Срок оценки: Up to approximately 41 months]
- Overall Survival (OS) [Срок оценки: Up to approximately 41 months]
- Time To Next Line of Therapy (TTNT) [Срок оценки: Up to approximately 41 months]
- Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity [Срок оценки: Up to approximately 41 months]
- Number of Participants with Abnormalities in Laboratory Parameters [Срок оценки: Up to approximately 41 months]
- Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores [Срок оценки: From Baseline up to approximately 41 months]
Критерии участия
Критерии включения
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
- Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
- Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Критерии исключения
- Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
- Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 26 центров
- Alabama Oncology — Birmingham
- Mayo Clinic 1 — Phoenix
- Highlands Oncology Group — Springdale
- Beverly Hills Cancer Center Clinical Research Advisors LLC — Beverly Hills
- Valkyrie Clinical Trials — Los Angeles
- Mayo Clinic Jacksonville — Jacksonville
- Memorial Cancer Institute — Pembroke Pines
- Emory University — Atlanta
- … и ещё 18 центров
Япония · 8 центров
- National Hospital Organization Kyushu Medical Center — Fukuoka
- Gunma University Hospital — Gunma
- University Hospital Kyoto Prefectural University of Medicine — Kyoto
- Matsuyama Red Cross Hospital — Matsuyama
- National Hospital Organization Okayama Medical Center — Okayama
- Sapporo City General Hospital — Sapporo
- The Cancer Institute Hospital of JFCR — Tokyo
- Kanagawa Cancer Center — Yokohama
Испания · 8 центров
- Hosp. Clinic de Barcelona — Barcelona
- Hosp. San Pedro de Alcantara — Cáceres
- Hosp Reina Sofia — Córdoba
- Hosp. de Jerez de La Frontera — Jerez de la Frontera
- Hosp. Univ. 12 de Octubre — Madrid
- Clinica Univ. de Navarra — Pamplona
- Hosp. Univ. Marques de Valdecilla — Santander
- Hosp. Virgen Del Rocio — Seville
Turkey (Türkiye) · 8 центров
Список центров уточняется — проверьте первичный протокол.
Израиль · 6 центров
- Samson Assuta Ashdod University Hospital — Ashdod
- Rambam Med.Center - Hematology Institute — Haifa
- Carmel Medical Center — Haifa
- Rabin Medical Center — Petah Tikva
- Sheba Medical Center — Ramat Gan
- Tel Aviv Sourasky Medical Center — Tel Aviv
South Korea · 5 центров
- Seoul National University Bundang Hospital — Gyeonggi-do
- Chonnam National University Hwasun Hospital — Hwasun
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- The Catholic University of Korea Seoul St Marys Hospital — Seoul
Тайвань · 5 центров
- China Medical University Hospital — Taichung
- Taichung Veterans General Hospital — Taichung
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
- Taipei Veterans General Hospital — Taipei
Греция · 4 центра
- Evangelismos S A — Athens
- Alexandra General Hospital of Athens — Athens
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara — Athens
- University General Hospital of Ioannina — Ioannina
Польша · 4 центра
- Pratia Onkologia Katowice — Katowice
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli — Lublin
- MTZ Clinical Research Powered by Pratia — Warsaw
- Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu — Wałbrzych
Франция · 3 центра
- CHU Nantes - Hotel Dieu — Nantes
- CHU Toulouse — Toulouse
- CHRU de Tours — Tours
Германия · 3 центра
- Universitaetsklinikum Freiburg — Freiburg im Breisgau
- Asklepios Klinik Altona — Hamburg
- Universitaetsklinik Tuebingen — Tübingen
Индия · 3 центра
- Bhagwan Mahaveer Cancer Hospital & Research Centre — Jaipur
- Nil Ratan Sircar Medical College and Hospital — Kolkata
- Deenanath Mangeshkar Hospital and Research Centre — Pune
Китай · 2 центра
- Beijing Chaoyang Hospital — Chaoyang District
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tijian
Италия · 2 центра
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara — Novara
- Casa di Cura La Maddalena — Palermo
Австралия · 1 центр
- St Vincent s Hospital Sydney — Darlinghurst
Идентификаторы
NCT: NCT07518186 · 79635322MMY3002