| Спонсоры |
Ведущий спонсор: Janssen Research & Development, LLC |
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| Источник | Janssen Research & Development, LLC |
| Краткое содержание | The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd). |
| Подробное описание | Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity , or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using IMWG criteria. The overall duration of the study will be up to 5 years and 2 months after the last participant is randomized. |
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| Общий статус | Recruiting | ||||||||||||||||||||||||||||||||||||||||
| Дата начала | 2021-10-14 | ||||||||||||||||||||||||||||||||||||||||
| Дата завершения | 2026-12-23 | ||||||||||||||||||||||||||||||||||||||||
| Дата первичного завершения | 2024-07-07 | ||||||||||||||||||||||||||||||||||||||||
| Фаза | Phase 3 | ||||||||||||||||||||||||||||||||||||||||
| Тип исследования | Interventional | ||||||||||||||||||||||||||||||||||||||||
| Первичный результат |
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| Вторичный результат |
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| Регистрация | 560 |
| Состояние |
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| Вмешательство |
Тип вмешательства: Drug Название вмешательства: Daratumumab Описание: Daratumumab will be administered SC injection. Тип вмешательства: Drug Название вмешательства: Pomalidomide Описание: Pomalidomide will be administered orally. Этикетка Arm Group: Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib, Dexamethasone (DVd) Тип вмешательства: Drug Название вмешательства: Dexamethasone Описание: Dexamethasone will be administered orally or IV. Этикетка Arm Group: Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib, Dexamethasone (DVd) Тип вмешательства: Drug Название вмешательства: Bortezomib Описание: Bortezomib will be administered SC injection. Этикетка Arm Group: Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib, Dexamethasone (DVd) Тип вмешательства: Drug Название вмешательства: Teclistamab Описание: Teclistamab will be administered SC injection. Этикетка Arm Group: Arm A: Teclistamab-daratumumab (Tec-Dara) Другое имя: JNJ-64007957 |
| Приемлемость |
Критерии: Inclusion Criteria: - Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the 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 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio - Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion - Documented evidence of progressive disease 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 - Have clinical laboratory values within the specified range Exclusion Criteria: - Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: 1. A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, 2. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization - Received any prior B cell maturation antigen (BCMA)-directed therapy - Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG - Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization - Received a live, attenuated vaccine within 4 weeks before randomization - Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis Пол: All Минимальный возраст: 18 Years Максимальный возраст: N/A Здоровые волонтеры: No |
| Общий Официальный |
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| Общий контакт |
Фамилия: Study Contact Телефон: 844-434-4210 |
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| Расположение |
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| Расположение Страны |
Argentina Belgium Brazil Canada China Denmark France Germany Greece Italy Japan Korea, Republic of Netherlands Russian Federation Spain Sweden Taiwan Ukraine United Kingdom United States |
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| Дата проверки |
2022-01-01 |
| Ответственная сторона |
Тип: Sponsor |
| Имеет расширенный доступ | No |
| Состояние Просмотр |
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| Количество рук | 2 |
| Группа вооружений |
Метка: Arm A: Teclistamab-daratumumab (Tec-Dara) Тип: Experimental Описание: Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose. Метка: Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib, Dexamethasone (DVd) Тип: Experimental Описание: In DPd treatment (28-day cycle), participants will receive daratumumab SC 1800mg weekly on Cycles 1 and 2, every 2 weeks on Cycles 3 to 6, every 4 weeks on Cycle 7 and beyond; oral pomalidomide 4 mg on Days 1 to 21 of every 28-day cycle, dexamethasone 40 mg (less than or equal to [<=] 75 years) or 20 mg (greater than [>] 75 years) orally or intravenously (IV) weekly on every cycle. In DVd treatment (21-day cycle from Cycles 1 to 8 and 28-day cycle from Cycle 9 and beyond), daratumumab SC injection 1800 mg weekly on Cycles 1 to 3 and on Day 1 (Cycle 4 and beyond); bortezomib 1.3 milligrams per meter square (mg/m^2) on Days 1, 4, 8 and 11 (Cycles 1 to 8), and dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8). |
| Акроним | MajesTEC-3 |
| Данные пациента | Yes |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: None (Open Label) |