- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: ABBVIE CALL CENTER
- Numero di telefono: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Luoghi di studio
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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, Canada, V8R 6V5
- British Columbia Cancer Agency Vancouver Centre /ID# 282147
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
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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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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Germania, 79106
- Universitaetsklinikum Freiburg /ID# 282874
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Karlsruhe, Baden-Wurttemberg, Germania, 76133
- Staedtisches Klinikum Karlsruhe /ID# 283569
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Tübingen, Baden-Wurttemberg, Germania, 72076
- Universitaetsklinikum Tuebingen /ID# 282873
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Ulm, Baden-Wurttemberg, Germania, 89081
- Universitaetsklinikum Ulm /ID# 283884
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Bavaria
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Würzburg, Bavaria, Germania, 97080
- Universitaetsklinikum Wuerzburg /ID# 283572
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Lower Saxony
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Hanover, Lower Saxony, Germania, 30459
- Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Germania, 53127
- Universitaetsklinikum Bonn /ID# 283881
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Cologne, North Rhine-Westphalia, Germania, 50937
- Universitaetsklinikum Koeln /ID# 283930
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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, Norvegia, 5021
- Haukeland University Hospital /ID# 283524
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South Holland
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Leiden, South Holland, Olanda, 2333 ZA
- Leids Universitair Medisch Centrum /ID# 283142
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Rotterdam, South Holland, Olanda, 3015 CE
- Erasmus Medisch Centrum /ID# 283408
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Braga, Portogallo, 4710-243
- 2CA-Braga, Hospital de Braga /ID# 283828
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Porto, Portogallo, 4200-319
- Unidade Local de Saude Sao Joao /ID# 283530
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Lisbon District
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Lisbon, Lisbon District, Portogallo, 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, Portogallo, 4434-502
- Unidade Local de Saude de Gaia/Espinho /ID# 283492
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Devon
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Plymouth, Devon, Regno Unito, PL6 8DH
- University Hospitals Plymouth NHS Trust /ID# 283108
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Edinburgh, City of
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Edinburgh, Edinburgh, City of, Regno Unito, EH4 2XU
- Western General Hospital - NHS Lothian /ID# 281838
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Greater London
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London, Greater London, Regno Unito, EC1A 7BE
- St Bartholomews Hospital - Barts Health /ID# 283714
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Hampshire
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Portsmouth, Hampshire, Regno Unito, PO6 3LY
- Queen Alexandra Hospital /ID# 281839
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North Lanarkshire
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Airdrie, North Lanarkshire, Regno Unito, ML6 0JS
- NHS Lanarkshire /ID# 282021
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Nottinghamshire
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Nottingham, Nottinghamshire, Regno Unito, NG5 1PB
- Nottingham City Hospital /ID# 282748
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Madrid, Spagna, 28007
- Hospital General Universitario Gregorio Maranon /ID# 283342
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Cantabria
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Santander, Cantabria, Spagna, 39008
- Hospital Universitario Marques de Valdecilla /ID# 283344
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Navarre
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Pamplona, Navarre, Spagna, 31008
- Clinica Universidad de Navarra - Pamplona /ID# 283290
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Arizona
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Tucson, Arizona, Stati Uniti, 85704
- University of Arizona Cancer Center /ID# 285339
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California
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Cerritos, California, Stati Uniti, 90703
- Toi Clinical Research - Whittier /ID# 284462
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Los Angeles, California, Stati Uniti, 90095-3075
- University of California Los Angeles /ID# 282444
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Colorado
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Aurora, Colorado, Stati Uniti, 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, Stati Uniti, 20007
- MedStar Georgetown University Hospital /ID# 283734
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Florida
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Weston, Florida, Stati Uniti, 33331
- Cleveland Clinic Florida /ID# 283692
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Georgia
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Marietta, Georgia, Stati Uniti, 30060
- Northwest Georgia Oncology Centers /ID# 284769
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center /ID# 283095
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center /ID# 285204
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 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, Stati Uniti, 10029
- The Mount Sinai Hospital /ID# 283535
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New York, New York, Stati Uniti, 10032
- Columbia University Medical Center /ID# 283510
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New York, New York, Stati Uniti, 10065
- Weill Cornell Medicine - Cornell University /ID# 283712
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Rochester, New York, Stati Uniti, 14642
- University of Rochester Medical Center /ID# 283480
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center /ID# 283475
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Winston-Salem, North Carolina, Stati Uniti, 27103
- Novant Health Forsyth Medical Center /ID# 283485
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Cleveland Medical Center /ID# 283527
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health and Science University /ID# 282023
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- SCRI Oncology Partners /ID# 281380
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Texas
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Houston, Texas, Stati Uniti, 77030-4000
- MD Anderson Houston /ID# 282622
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute /ID# 283512
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Virginia
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Richmond, Virginia, Stati Uniti, 23298
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Hospitals and Clinics /ID# 282516
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Kaohsiung City, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital /ID# 282970
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Vas County
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Szombathely, Vas County, Ungheria, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
|
Injection
Oral
|
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Sperimentale: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
|
Injection
Oral
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Comparatore attivo: 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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Iniezione
Iniezione
Oral or Injection
Injection
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Safety Run-In: Number of Participants With Adverse Events (AE)s
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Approximately 12 Months
|
Cmax of Etentamig.
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Up to Approximately 12 Months
|
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Safety Run-In: Immunogenicity of Etentamig
Lasso di tempo: 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
Lasso di tempo: 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.
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Up to Approximately 75 Months
|
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Randomized Portion: Overall Survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Approximately 75 Months
|
Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
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Up to Approximately 75 Months
|
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Randomized Portion: BOR Per IRC Assessment
Lasso di tempo: 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
|
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Randomized Portion: VGPR or Better Rate Per IRC Assessment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
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Up to Approximately 75 Months
|
|
Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: ABBVIE INC., AbbVie
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Processi patologici
- Attributi della malattia
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Neoplasie, plasmacellule
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Condizioni patologiche, segni e sintomi
- Malattie emiche e linfatiche
- Neoplasie
- Ricorrenza
- Mieloma multiplo
- Composti policiclici
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Incintadienetrioli
- Desametasone
- carfilzomib
- pomalidomide
- daratumumab
Altri numeri di identificazione dello studio
- M22-538
- 2026-525596-11-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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