Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 3 NCT05572515

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

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

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.
Кой може да участва
Inclusion Criteria: * Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line * Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment * Must be willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: * Received any prior B cell maturation antigen (BCMA)-directed therapy * A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (\>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic blood pressure \>99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade \>=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event \[AE\] related to carfilzomib) * Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization * Received a live, attenuated vaccine within 4 weeks before randomization * Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma * Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
Места на провеждане 21
Австралия (1)
Blacktown Hospital
Blacktown
Белгия (1)
Algemeen Ziekenhuis Klina
Brasschaat
Бразилия (1)
Hospitais Integradaos da Gavea S/A - DF Star
Brasília
Канада (1)
Arthur J E Child Comprehensive Cancer Centre
Calgary , Alberta
Китай (1)
Beijing Chaoyang Hospital
Beijing
Чехия (1)
Fakultni nemocnice Brno
Brno
Дания (1)
Aalborg University Hospital
Aalborg
Франция (1)
CHU Amiens - Hopital Sud
Amiens
Гърция (1)
Alexandra General Hospital of Athens
Athens Attica
Индия (1)
Fortis Memorial Research Institute
Gurgaon
Израел (1)
Hillel Yaffe Medical Center
Hadera
Италия (1)
A O U Sant Orsola Malpighi
Bologna
Япония (1)
Institute of Science Tokyo Hospital
Bunkyō City
Malaysia (1)
Hospital Pulau Pinang
George Town
Нидерландия (1)
Meander Medisch Centrum
Amersfoort
Полша (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Испания (1)
Hosp. Univ. Germans Trias I Pujol
Badalona
Швеция (1)
Falu Lasarett Medicinkliniken Falun
Falun
Турция (1)
Ankara Gulhane Training and Research Hospital
Ankara
Великобритания (1)
Aberdeen Royal Infirmary
Aberdeen
САЩ (1)
Alaska Oncology and Hematology LLC
Anchorage , Alaska
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.03.2023
Крайна дата
31.08.2031
Регистрационен номер
NCT05572515
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.