- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Alemania, 79106
- Universitaetsklinikum Freiburg /ID# 282874
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Karlsruhe, Baden-Wurttemberg, Alemania, 76133
- Staedtisches Klinikum Karlsruhe /ID# 283569
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Tübingen, Baden-Wurttemberg, Alemania, 72076
- Universitaetsklinikum Tuebingen /ID# 282873
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Ulm, Baden-Wurttemberg, Alemania, 89081
- Universitaetsklinikum Ulm /ID# 283884
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Bavaria
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Würzburg, Bavaria, Alemania, 97080
- Universitaetsklinikum Wuerzburg /ID# 283572
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Lower Saxony
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Hanover, Lower Saxony, Alemania, 30459
- Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Alemania, 53127
- Universitaetsklinikum Bonn /ID# 283881
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Cologne, North Rhine-Westphalia, Alemania, 50937
- Universitaetsklinikum Koeln /ID# 283930
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New South Wales
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Wollongong, New South Wales, Australia, 2500
- Wollongong Hospital. /ID# 282694
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Queensland
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Benowa, Queensland, Australia, 4217
- Pindara Private Hospital /ID# 283010
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South Brisbane, Queensland, Australia, 4101
- Icon Cancer Care - South Brisbane /ID# 282965
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Victoria
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre. /ID# 282692
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Richmond, Victoria, Australia, 3121
- Epworth Hospital - Richmond /ID# 281877
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital /ID# 281879
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital /ID# 281881
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British Columbia
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Victoria, British Columbia, Canadá, V8R 6V5
- British Columbia Cancer Agency Vancouver Centre /ID# 282147
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Ontario
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London, Ontario, Canadá, N6A 5W9
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
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Madrid, España, 28007
- Hospital General Universitario Gregorio Maranon /ID# 283342
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Cantabria
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Santander, Cantabria, España, 39008
- Hospital Universitario Marques de Valdecilla /ID# 283344
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Navarre
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Pamplona, Navarre, España, 31008
- Clinica Universidad de Navarra - Pamplona /ID# 283290
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Arizona
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Tucson, Arizona, Estados Unidos, 85704
- University of Arizona Cancer Center /ID# 285339
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California
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Cerritos, California, Estados Unidos, 90703
- Toi Clinical Research - Whittier /ID# 284462
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Los Angeles, California, Estados Unidos, 90095-3075
- University of California Los Angeles /ID# 282444
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Colorado
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Aurora, Colorado, Estados Unidos, 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, Estados Unidos, 20007
- MedStar Georgetown University Hospital /ID# 283734
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Florida
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Weston, Florida, Estados Unidos, 33331
- Cleveland Clinic Florida /ID# 283692
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Northwest Georgia Oncology Centers /ID# 284769
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center /ID# 283095
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center /ID# 285204
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 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, Estados Unidos, 10029
- The Mount Sinai Hospital /ID# 283535
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center /ID# 283510
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New York, New York, Estados Unidos, 10065
- Weill Cornell Medicine - Cornell University /ID# 283712
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center /ID# 283480
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center /ID# 283475
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Novant Health Forsyth Medical Center /ID# 283485
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center /ID# 283527
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University /ID# 282023
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- SCRI Oncology Partners /ID# 281380
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Texas
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Houston, Texas, Estados Unidos, 77030-4000
- MD Anderson Houston /ID# 282622
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute /ID# 283512
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Hospitals and Clinics /ID# 282516
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Francia, 06202
- Chu de Nice-Hopital Larchet Ii /Id# 283541
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Indre-et-Loire
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Tours, Indre-et-Loire, Francia, 37044
- CHRU Tours - Hopital Bretonneau /ID# 281925
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Francia, 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, Francia, 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, Francia, 84000
- Centre Hospitalier d'Avignon /ID# 283509
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Vas County
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Szombathely, Vas County, Hungría, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italia, 47014
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
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Sogn Og Fjordane
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Bergen, Sogn Og Fjordane, Noruega, 5021
- Haukeland University Hospital /ID# 283524
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South Holland
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Leiden, South Holland, Países Bajos, 2333 ZA
- Leids Universitair Medisch Centrum /ID# 283142
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Rotterdam, South Holland, Países Bajos, 3015 CE
- Erasmus Medisch Centrum /ID# 283408
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Braga, Portugal, 4710-243
- 2CA-Braga, Hospital de Braga /ID# 283828
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Porto, Portugal, 4200-319
- Unidade Local de Saude Sao Joao /ID# 283530
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Lisbon District
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Lisbon, Lisbon District, Portugal, 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, Portugal, 4434-502
- Unidade Local de Saude de Gaia/Espinho /ID# 283492
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Devon
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Plymouth, Devon, Reino Unido, PL6 8DH
- University Hospitals Plymouth NHS Trust /ID# 283108
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Edinburgh, City of
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Edinburgh, Edinburgh, City of, Reino Unido, EH4 2XU
- Western General Hospital - NHS Lothian /ID# 281838
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Greater London
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London, Greater London, Reino Unido, EC1A 7BE
- St Bartholomews Hospital - Barts Health /ID# 283714
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Hampshire
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Portsmouth, Hampshire, Reino Unido, PO6 3LY
- Queen Alexandra Hospital /ID# 281839
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North Lanarkshire
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Airdrie, North Lanarkshire, Reino Unido, ML6 0JS
- NHS Lanarkshire /ID# 282021
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Nottinghamshire
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Nottingham, Nottinghamshire, Reino Unido, NG5 1PB
- Nottingham City Hospital /ID# 282748
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Kaohsiung City, Taiwán, 833
- Kaohsiung Chang Gung Memorial Hospital /ID# 282970
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Experimental: 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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Comparador activo: 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.
|
Inyección
Inyección
Oral or Injection
Injection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety Run-In: Number of Participants With Adverse Events (AE)s
Periodo de tiempo: Up to Approximately 75 Months
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Up to Approximately 75 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to Approximately 75 Months
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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
Periodo de tiempo: Up to Approximately 75 Months
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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.
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Up to Approximately 75 Months
|
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Randomized Portion: Overall Survival (OS)
Periodo de tiempo: 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.
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Up to Approximately 75 Months
|
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Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity
Periodo de tiempo: Up to Approximately 75 Months
|
Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).
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Up to Approximately 75 Months
|
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Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment
Periodo de tiempo: 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
|
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Randomized Portion: BOR Per IRC Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Neoplasias
- Reaparición
- Mieloma múltiple
- Compuestos policíclicos
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Esparrazadienetrioles
- Dexametasona
- carfilzomib
- pomalidomida
- daratumumab
Otros números de identificación del estudio
- M22-538
- 2026-525596-11-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .