- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07728188
A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma
A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)
Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide.
Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide.
Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: ABBVIE CALL CENTER
- Номер телефона: 844-663-3742
- Электронная почта: abbvieclinicaltrials@abbvie.com
Места учебы
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New South Wales
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Wollongong, New South Wales, Австралия, 2500
- Wollongong Hospital. /ID# 282694
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Queensland
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Benowa, Queensland, Австралия, 4217
- Pindara Private Hospital /ID# 283010
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South Brisbane, Queensland, Австралия, 4101
- Icon Cancer Care - South Brisbane /ID# 282965
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Victoria
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Melbourne, Victoria, Австралия, 3000
- Peter MacCallum Cancer Centre. /ID# 282692
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Richmond, Victoria, Австралия, 3121
- Epworth Hospital - Richmond /ID# 281877
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Western Australia
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Murdoch, Western Australia, Австралия, 6150
- Fiona Stanley Hospital /ID# 281879
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Nedlands, Western Australia, Австралия, 6009
- Sir Charles Gairdner Hospital /ID# 281881
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Vas County
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Szombathely, Vas County, Венгрия, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Германия, 79106
- Universitaetsklinikum Freiburg /ID# 282874
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Karlsruhe, Baden-Wurttemberg, Германия, 76133
- Staedtisches Klinikum Karlsruhe /ID# 283569
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Tübingen, Baden-Wurttemberg, Германия, 72076
- Universitaetsklinikum Tuebingen /ID# 282873
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Ulm, Baden-Wurttemberg, Германия, 89081
- Universitaetsklinikum Ulm /ID# 283884
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Bavaria
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Würzburg, Bavaria, Германия, 97080
- Universitaetsklinikum Wuerzburg /ID# 283572
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Lower Saxony
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Hanover, Lower Saxony, Германия, 30459
- Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Германия, 53127
- Universitaetsklinikum Bonn /ID# 283881
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Cologne, North Rhine-Westphalia, Германия, 50937
- Universitaetsklinikum Koeln /ID# 283930
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Madrid, Испания, 28007
- Hospital General Universitario Gregorio Maranon /ID# 283342
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Cantabria
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Santander, Cantabria, Испания, 39008
- Hospital Universitario Marques de Valdecilla /ID# 283344
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Navarre
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Pamplona, Navarre, Испания, 31008
- Clinica Universidad de Navarra - Pamplona /ID# 283290
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Forlì-Cesena
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Meldola, Forlì-Cesena, Италия, 47014
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
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British Columbia
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Victoria, British Columbia, Канада, V8R 6V5
- British Columbia Cancer Agency Vancouver Centre /ID# 282147
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Ontario
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London, Ontario, Канада, N6A 5W9
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
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Quebec
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Montreal, Quebec, Канада, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
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South Holland
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Leiden, South Holland, Нидерланды, 2333 ZA
- Leids Universitair Medisch Centrum /ID# 283142
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Rotterdam, South Holland, Нидерланды, 3015 CE
- Erasmus Medisch Centrum /ID# 283408
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Sogn Og Fjordane
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Bergen, Sogn Og Fjordane, Норвегия, 5021
- Haukeland University Hospital /ID# 283524
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Braga, Португалия, 4710-243
- 2CA-Braga, Hospital de Braga /ID# 283828
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Porto, Португалия, 4200-319
- Unidade Local de Saude Sao Joao /ID# 283530
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Lisbon District
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Lisbon, Lisbon District, Португалия, 1449-005
- Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
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Porto District
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Vila Nova de Gaia, Porto District, Португалия, 4434-502
- Unidade Local de Saude de Gaia/Espinho /ID# 283492
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Devon
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Plymouth, Devon, Соединенное Королевство, PL6 8DH
- University Hospitals Plymouth NHS Trust /ID# 283108
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Edinburgh, City of
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Edinburgh, Edinburgh, City of, Соединенное Королевство, EH4 2XU
- Western General Hospital - NHS Lothian /ID# 281838
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Greater London
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London, Greater London, Соединенное Королевство, EC1A 7BE
- St Bartholomews Hospital - Barts Health /ID# 283714
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Hampshire
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Portsmouth, Hampshire, Соединенное Королевство, PO6 3LY
- Queen Alexandra Hospital /ID# 281839
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North Lanarkshire
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Airdrie, North Lanarkshire, Соединенное Королевство, ML6 0JS
- NHS Lanarkshire /ID# 282021
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Nottinghamshire
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Nottingham, Nottinghamshire, Соединенное Королевство, NG5 1PB
- Nottingham City Hospital /ID# 282748
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Arizona
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Tucson, Arizona, Соединенные Штаты, 85704
- University of Arizona Cancer Center /ID# 285339
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California
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Cerritos, California, Соединенные Штаты, 90703
- Toi Clinical Research - Whittier /ID# 284462
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Los Angeles, California, Соединенные Штаты, 90095-3075
- University of California Los Angeles /ID# 282444
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- University Of Colorado - Anschutz Medical Campus /ID# 283478
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District of Columbia
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Washington D.C., District of Columbia, Соединенные Штаты, 20007
- MedStar Georgetown University Hospital /ID# 283734
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Florida
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Weston, Florida, Соединенные Штаты, 33331
- Cleveland Clinic Florida /ID# 283692
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Georgia
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Marietta, Georgia, Соединенные Штаты, 30060
- Northwest Georgia Oncology Centers /ID# 284769
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Rush University Medical Center /ID# 283095
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02215
- Beth Israel Deaconess Medical Center /ID# 285204
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Michigan
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Grand Rapids, Michigan, Соединенные Штаты, 49503
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
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New York
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New York, New York, Соединенные Штаты, 10029
- The Mount Sinai Hospital /ID# 283535
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New York, New York, Соединенные Штаты, 10032
- Columbia University Medical Center /ID# 283510
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New York, New York, Соединенные Штаты, 10065
- Weill Cornell Medicine - Cornell University /ID# 283712
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Rochester, New York, Соединенные Штаты, 14642
- University of Rochester Medical Center /ID# 283480
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North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27599
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
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Durham, North Carolina, Соединенные Штаты, 27710
- Duke University Medical Center /ID# 283475
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
- Novant Health Forsyth Medical Center /ID# 283485
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44106
- University Hospitals Cleveland Medical Center /ID# 283527
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Oregon
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Portland, Oregon, Соединенные Штаты, 97239
- Oregon Health and Science University /ID# 282023
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37203
- SCRI Oncology Partners /ID# 281380
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Texas
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Houston, Texas, Соединенные Штаты, 77030-4000
- MD Anderson Houston /ID# 282622
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84112
- Huntsman Cancer Institute /ID# 283512
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23298
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53792
- University of Wisconsin Hospitals and Clinics /ID# 282516
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Kaohsiung City, Тайвань, 833
- Kaohsiung Chang Gung Memorial Hospital /ID# 282970
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Франция, 06202
- Chu de Nice-Hopital Larchet Ii /Id# 283541
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Indre-et-Loire
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Tours, Indre-et-Loire, Франция, 37044
- CHRU Tours - Hopital Bretonneau /ID# 281925
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Франция, 54511
- Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Франция, 44000
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
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Provence-Alpes-Côte d'Azur Region
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Avignon, Provence-Alpes-Côte d'Azur Region, Франция, 84000
- Centre Hospitalier d'Avignon /ID# 283509
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
- Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
- Adequate organ function and performance status
Exclusion Criteria:
- Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
- Known central nervous system involvement of MM
- Known history of other active malignancies within the past 3 years (with specific exceptions)
- Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
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Injection
Oral
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Экспериментальный: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
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Injection
Oral
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Активный компаратор: Randomized Portion: Standard Available Therapy (SAT)
Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.
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Инъекция
Инъекция
Oral or Injection
Injection
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Safety Run-In: Number of Participants With Adverse Events (AE)s
Временное ограничение: Up to Approximately 75 Months
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AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Up to Approximately 75 Months
|
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Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
Временное ограничение: Up to Approximately 75 Months
|
CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria.
CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates.
The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).
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Up to Approximately 75 Months
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Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Временное ограничение: Up to Approximately 75 Months
|
PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.
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Up to Approximately 75 Months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Временное ограничение: Up to Approximately 75 Months
|
BOR is defined as the best response achieved across all response assessments, partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR), from randomization until disease progression per investigator assessment, using IMWG (2016) response criteria.
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Up to Approximately 75 Months
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Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Временное ограничение: Up to Approximately 12 Months
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Cmax of Etentamig.
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Up to Approximately 12 Months
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Safety Run-In: Time to Cmax (Tmax) of Etentamig
Временное ограничение: Up to Approximately 12 Months
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Cmax of Etentamig.
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Up to Approximately 12 Months
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Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig
Временное ограничение: Up to Approximately 12 Months
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Cmax of Etentamig.
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Up to Approximately 12 Months
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Safety Run-In: Immunogenicity of Etentamig
Временное ограничение: Up to Approximately 75 Months
|
Immunogenicity of etentamig is defined as the summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antibody (NAb)s, if NAb samples are analyzed.
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Up to Approximately 75 Months
|
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Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
MRDnegCR is defined as achievement of CR or better by IMWG (2016) response criteria per IRC assessment and MRD negative status as assessed by next-generation sequencing (NGS) at threshold defined in the protocol.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Overall Survival (OS)
Временное ограничение: Up to Approximately 75 Months
|
Overall Survival (OS) is defined as the duration from the date of randomization to the date of death from any cause.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity
Временное ограничение: Up to Approximately 75 Months
|
Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).
|
Up to Approximately 75 Months
|
|
Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
|
Up to Approximately 75 Months
|
|
Randomized Portion: BOR Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
BOR is defined as the best response achieved across all response assessments, PR + VGPR + CR +sCR from randomization until disease progression per IRC assessment, using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
|
Randomized Portion: VGPR or Better Rate Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
VGPR or better rate per IRC assessment, defined as percentage of participants achieving VGPR, CR, or sCR using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Time to Response (TTR) Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
TTR is defined as the time from randomization to first documented response (PR or better) per IRC assessment using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Duration of Response (DOR) Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
DOR is defined as the time from first documented response (PR or better) to disease progression or death, whichever occurs first, per IRC assessment using IMWG (2016) response criteria.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Second Progression-Free Survival (PFS2)
Временное ограничение: Up to Approximately 75 Months
|
PFS2 is defined as time from randomization to second disease progression or death from any cause, whichever occurs first.
|
Up to Approximately 75 Months
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (QoL) Score
Временное ограничение: Up to Approximately 75 Months
|
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life score.
Patient-reported outcome (PRO) assessment.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment
Временное ограничение: Up to Approximately 75 Months
|
EFS per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
|
Up to Approximately 75 Months
|
|
Randomized Portion: Time to Next Treatment (TTNT)
Временное ограничение: Up to Approximately 75 Months
|
TTNT is defined as time from randomization to initiation of next anti-myeloma therapy.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Time to Symptomatic Disease Progression
Временное ограничение: Up to Approximately 75 Months
|
Time to symptomatic disease progression in participants with relapsed/refractory multiple myeloma (RRMM).
|
Up to Approximately 75 Months
|
|
Randomized Portion: Change From Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma Module (EORTC QLQ-MY20)
Временное ограничение: Up to Approximately 75 Months
|
Change from baseline in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20 .
|
Up to Approximately 75 Months
|
|
Randomized Portion: Change From Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Временное ограничение: Up to Approximately 75 Months
|
Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30.
|
Up to Approximately 75 Months
|
|
Randomized Portion: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 (FACT-G GP5)
Временное ограничение: Up to Approximately 75 Months
|
Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 FACT-G GP5.
Patient-reported outcome (PRO) assessment.
|
Up to Approximately 75 Months
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: ABBVIE INC., AbbVie
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
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
Дополнительные соответствующие термины MeSH
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Патологические процессы
- Атрибуты болезни
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Гематологические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Новообразования, Плазматические клетки
- Нарушения гемостаза
- Парапротеинемии
- Нарушения белков крови
- Геморрагические расстройства
- Патологические состояния, признаки и симптомы
- Гемики и лимфатические заболевания
- Новообразования
- Повторение
- Множественная миелома
- Полициклические соединения
- Беременные
- Беременные
- Стероиды
- Соединения слитого кольца
- Стероиды, фторированные
- Bergyadienetriols
- Дексаметазон
- Карфилзомиб
- Помалидомид
- даратумумаб
Другие идентификационные номера исследования
- M22-538
- 2026-525596-11-00 (Ктис)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
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.
продукт, произведенный в США и экспортированный из 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. .