Исследование талкетамаба у участников с рецидивирующей или рефрактерной множественной миеломой (MonumenTAL-1)
Фаза 1/2, первое открытое исследование с повышением дозы талкетамаба, гуманизированного биспецифического антитела GPRC5D x CD3, у людей с рецидивирующей или рефрактерной множественной миеломой
The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Расширенный доступ
Контакты и местонахождение
Контакты исследования
- Имя: Study Contact
- Номер телефона: 844-434-4210
- Электронная почта: Participate-In-This-Study1@its.jnj.com
Места учебы
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Edegem, Бельгия, 2650
- Завершенный
- UZ Antwerpen
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Leuven, Бельгия, 3000
- Активный, не рекрутирующий
- UZ Leuven
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Liège, Бельгия, 4000
- Активный, не рекрутирующий
- CHU de Liège - Domaine Universitaire du Sart Tilman
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Woluwe-Saint-Lambert, Бельгия, 1200
- Завершенный
- UCL - Saint Luc
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Berlin, Германия, 12203
- Активный, не рекрутирующий
- Charite Campus Benjamin Franklin
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Heidelberg, Германия, 69120
- Активный, не рекрутирующий
- Universitaetsklinikum Heidelberg
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Münster, Германия, 48149
- Завершенный
- Universitaetsklinikum Muenster
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Würzburg, Германия, 97080
- Активный, не рекрутирующий
- Universitatsklinikum Wurzburg
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Haifa, Израиль, 31096
- Активный, не рекрутирующий
- Rambam Medical Center
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Haifa, Израиль, 3436212
- Активный, не рекрутирующий
- Carmel Medical Center
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Jerusalem, Израиль, 91120
- Активный, не рекрутирующий
- Hadassah Medical Center
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Ramat Gan, Израиль, 52621
- Активный, не рекрутирующий
- Sheba Medical Center
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Tel Aviv, Израиль, 64239
- Активный, не рекрутирующий
- Tel Aviv Sourasky Medical Center
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Badalona, Испания, 08916
- Завершенный
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Испания, 8908
- Активный, не рекрутирующий
- Inst. Cat. Doncologia-H Duran I Reynals
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Barcelona, Испания, 08035
- Рекрутинг
- Hosp Univ Vall D Hebron
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Madrid, Испания, 28041
- Завершенный
- Hosp. Univ. 12 de Octubre
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Madrid, Испания, 28040
- Завершенный
- Hosp Univ Fund Jimenez Diaz
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Murcia, Испания, 30120
- Активный, не рекрутирующий
- Hosp. Univ. Virgen de La Arrixaca
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Pamplona, Испания, 31008
- Рекрутинг
- Clinica Univ. de Navarra
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Pozuelo de Alarcón, Испания, 28223
- Завершенный
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Испания, 37007
- Рекрутинг
- Hosp Clinico Univ de Salamanca
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Santander, Испания, 39008
- Рекрутинг
- Hosp. Univ. Marques de Valdecilla
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Seville, Испания, 41013
- Рекрутинг
- Hosp. Virgen Del Rocio
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Beijing, Китай, 100191
- Завершенный
- Peking University Third Hospital
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Guangzhou, Китай, 510060
- Активный, не рекрутирующий
- Sun Yat Sen University Cancer Center
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Hangzhou, Китай, 310003
- Активный, не рекрутирующий
- The 1St Affiliated Hospital of Medical College Zhejiang University
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Hangzhou, Китай, 310003
- Активный, не рекрутирующий
- The 1st Affiliated Hospital Of Medical College Zhejiang University 1
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Suzhou, Китай, 215006
- Активный, не рекрутирующий
- First Affiliated Hospital SooChow University
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Tianjin, Китай, 300320
- Активный, не рекрутирующий
- Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
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Xi'an, Китай, 710004
- Завершенный
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Китай, 710063
- Завершенный
- The First Affiliated Hospital of Xian Jiaotong University
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Amsterdam, Нидерланды, 1081 HV
- Завершенный
- VU Medisch Centrum
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Utrecht, Нидерланды, 3584 CX
- Завершенный
- UMCU
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Gdansk, Польша, 80 214
- Активный, не рекрутирующий
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Польша, 44102
- Завершенный
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Poznan, Польша, 60-569
- Активный, не рекрутирующий
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warsaw, Польша, 02-781
- Завершенный
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Wroclaw, Польша, 50 367
- Активный, не рекрутирующий
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35294
- Рекрутинг
- University of Alabama Birmingham
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Arkansas
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Little Rock, Arkansas, Соединенные Штаты, 72205
- Рекрутинг
- University of Arkansas for Medical Sciences
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California
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Duarte, California, Соединенные Штаты, 91010
- Завершенный
- City of Hope
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Florida
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Hollywood, Florida, Соединенные Штаты, 33021
- Рекрутинг
- Memorial Healthcare System
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- Рекрутинг
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60637
- Завершенный
- University of Chicago
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40207
- Рекрутинг
- Norton Cancer Institute
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- Рекрутинг
- University of Michigan Health System
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Missouri
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St Louis, Missouri, Соединенные Штаты, 63110
- Рекрутинг
- Washington University School Of Medicine
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New York
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New York, New York, Соединенные Штаты, 10023
- Рекрутинг
- Mount Sinai Medical Center
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New York, New York, Соединенные Штаты, 10016
- Активный, не рекрутирующий
- NYU Langone Health
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Rochester, New York, Соединенные Штаты, 14642
- Рекрутинг
- University of Rochester Medical Center
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Oregon
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Portland, Oregon, Соединенные Штаты, 97213
- Завершенный
- Providence Portland Medical Center
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37203
- Завершенный
- Tennessee Oncology
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Créteil, Франция, 94000
- Активный, не рекрутирующий
- CHU Henri Mondor
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Lyon, Франция, 69002
- Активный, не рекрутирующий
- Hospices Civils de Lyon HCL
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Montpellier, Франция, 34295
- Активный, не рекрутирующий
- CHU de Montpellier Hopital Saint Eloi
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Nantes, Франция, 44093
- Активный, не рекрутирующий
- C.H.U. Hotel Dieu - France
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Pessac, Франция, 33604
- Активный, не рекрутирующий
- CHU de Bordeaux - Hospital Haut-Leveque
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Toulouse, Франция, 31059
- Активный, не рекрутирующий
- Pôle IUC Oncopole CHU
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Jeollanam-do, Южная Корея, 58128
- Завершенный
- Chonnam National University Hwasun Hospital
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Seoul, Южная Корея, 06351
- Завершенный
- Samsung Medical Center
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Seoul, Южная Корея, 05505
- Завершенный
- Asan Medical Center
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Seoul, Южная Корея, 03080
- Завершенный
- Seoul National University Hospital
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Seoul, Южная Корея, 03722
- Завершенный
- Severance Hospital Yonsei University Health System
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Seoul, Южная Корея, 06591
- Завершенный
- The Catholic University of Korea Seoul St Marys Hospital
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Chiba, Япония, 296-8602
- Завершенный
- Kameda Medical Center
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Fukuoka, Япония, 814-0180
- Завершенный
- Fukuoka University Hospital
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Gifu, Япония, 503-8502
- Завершенный
- Ogaki Municipal Hospital
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Hokkaido, Япония, 006-8555
- Завершенный
- Teine Keijinkai Hospital
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Kobe, Япония, 650 0047
- Завершенный
- Kobe City Medical Center General Hospital
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Koshigaya, Япония, 343-8555
- Завершенный
- Dokkyo Medical University Saitama Medical Center
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Kumamoto, Япония, 860-8556
- Завершенный
- Kumamoto University Hospital
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Kurashiki, Япония, 710-8602
- Завершенный
- Kurashiki Central Hospital
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Matsumoto, Япония, 399-8701
- Завершенный
- National Hospital Organization Matsumoto Medical Center
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Okayama, Япония, 701-1192
- Завершенный
- National Hospital Organization Okayama Medical Center
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Osaka, Япония, 543 8555
- Завершенный
- Japanese Red Cross Osaka Hospital
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Shiwa-gun, Япония, 028-3695
- Завершенный
- Iwate Medical University Hospital
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Ōtake, Япония, 739-0696
- Активный, не рекрутирующий
- National Hospital Organization Hiroshima-Nishi Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
- Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
- Stroke or seizure within 6 months prior to signing the informed consent form (ICF)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Part 3: Cohort A (Talquetamab)
Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Другие имена:
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|
Экспериментальный: Part 3: Cohort B (Talquetamab)
Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Другие имена:
|
|
Экспериментальный: Part 3: Cohort C (Talquetamab)
Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Другие имена:
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|
Экспериментальный: Part 3: Cohort D (Talquetamab)
Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Другие имена:
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Экспериментальный: Part 3: Cohort E (Talquetamab)
Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Overall Response Rate (ORR)
Временное ограничение: Up to 2 years and 10 months
|
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria. |
Up to 2 years and 10 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Duration of Response (DOR)
Временное ограничение: Up to 2 years and 10 months
|
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first. |
Up to 2 years and 10 months
|
|
Very Good Partial Response (VGPR) or Better Rate
Временное ограничение: Up to 2 years and 10 months
|
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Complete Response (CR) or Better Rate
Временное ограничение: Up to 2 years and 10 months
|
CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Stringent Complete Response (sCR) Rate
Временное ограничение: Up to 2 years and 10 months
|
sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Time to Response (TTR)
Временное ограничение: Up to 2 years and 10 months
|
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. |
Up to 2 years and 10 months
|
|
Progression-Free Survival (PFS)
Временное ограничение: Up to 2 years and 10 months
|
PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. |
Up to 2 years and 10 months
|
|
Overall Survival (OS)
Временное ограничение: Up to 2 years and 10 months
|
OS is defined as the time from the date of first dose of study drug to the date of the participant's death. |
Up to 2 years and 10 months
|
|
Minimal Residual Disease (MRD) Negative Rate
Временное ограничение: Up to 2 years and 10 months
|
MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data. |
Up to 2 years and 10 months
|
|
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Временное ограничение: Up to 2 years and 10 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 2 years and 10 months
|
|
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Временное ограничение: Up to 2 years and 10 months
|
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Up to 2 years and 10 months
|
|
Number of Participants with AEs by Severity
Временное ограничение: Up to 2 years and 10 months
|
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. |
Up to 2 years and 10 months
|
|
Number of Participants with Abnormalities in Clinical Laboratory Values
Временное ограничение: Up to 2 years and 10 months
|
Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported. |
Up to 2 years and 10 months
|
|
Serum Concentration of Talquetamab
Временное ограничение: Up to 2 years and 10 months
|
Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 2 years and 10 months
|
|
Number of Participants with Talquetamab Antibodies
Временное ограничение: Up to 2 years and 10 months
|
Antibodies to talquetamab will be assessed to evaluate potential immunogenicity. |
Up to 2 years and 10 months
|
|
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
Временное ограничение: Baseline up to 2 years and 10 months
|
The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. |
Baseline up to 2 years and 10 months
|
|
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Временное ограничение: Baseline up to 2 years and 10 months
|
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers. |
Baseline up to 2 years and 10 months
|
|
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
Временное ограничение: Baseline up to 2 years and 10 months
|
The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe). |
Baseline up to 2 years and 10 months
|
|
Overall Response Rate (ORR) in Participants with High-risk Molecular Features
Временное ограничение: Up to 2 years and 10 months
|
ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes. |
Up to 2 years and 10 months
|
Соавторы и исследователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Публикации и полезные ссылки
Общие публикации
- Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
- Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Qin X, Kato K, Bathija S, Katz EG, Gries KS, Campagna M, Masterson T, Hilder BW, Tolbert J, Renaud T, Heuck C, Tomlinson C, Moreau P, San-Miguel J, Rodriguez-Otero P, Chari A. Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study. Cancer. 2025 Jul 15;131(14):e35927. doi: 10.1002/cncr.35927.
- Chari A, Touzeau C, Schinke C, Minnema MC, Berdeja JG, Oriol A, van de Donk NWCJ, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Vishwamitra D, Skerget S, Verona R, Ma X, Qin X, Ludlage H, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Goldberg JD, Kane C, Heuck C, San-Miguel J, Moreau P. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025 Apr;12(4):e269-e281. doi: 10.1016/S2352-3026(24)00385-5. Epub 2025 Mar 13.
- van de Donk NWCJ, Chari A, Martin T, Krishnan A, Rasche L, Ye JC, Popat R, Lipe B, Rodriguez C, Schinke C, Skerget S, Vishwamitra D, Verona R, Gong J, Singh I, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Smit MD, Heuck C, Mateos MV. Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma. Cancer Med. 2025 Oct;14(19):e71276. doi: 10.1002/cam4.71276.
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Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Новообразования по локализации
- Новообразования
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Гематологические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Новообразования, Плазматические клетки
- Нарушения гемостаза
- Парапротеинемии
- Нарушения белков крови
- Геморрагические расстройства
- Гемики и лимфатические заболевания
- Гематологические новообразования
- Множественная миелома
- Talquetamab
Другие идентификационные номера исследования
- CR108920
- 2017-002400-26 (Номер EudraCT)
- TALMMY1001-PT3 (Другой идентификатор: Janssen Research & Development, LLC)
- 2017 (Грант/контракт NIH США)
- 2023-504581-29-00 (Идентификатор реестра: EUCT number)
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .