- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studiesteder
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New South Wales
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Wollongong, New South Wales, Australien, 2500
- Wollongong Hospital. /ID# 282694
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Queensland
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Benowa, Queensland, Australien, 4217
- Pindara Private Hospital /ID# 283010
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South Brisbane, Queensland, Australien, 4101
- Icon Cancer Care - South Brisbane /ID# 282965
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Victoria
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Melbourne, Victoria, Australien, 3000
- Peter MacCallum Cancer Centre. /ID# 282692
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Richmond, Victoria, Australien, 3121
- Epworth Hospital - Richmond /ID# 281877
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Western Australia
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Murdoch, Western Australia, Australien, 6150
- Fiona Stanley Hospital /ID# 281879
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Nedlands, Western Australia, Australien, 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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Devon
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Plymouth, Devon, Det Forenede Kongerige, PL6 8DH
- University Hospitals Plymouth NHS Trust /ID# 283108
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Edinburgh, City of
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Edinburgh, Edinburgh, City of, Det Forenede Kongerige, EH4 2XU
- Western General Hospital - NHS Lothian /ID# 281838
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Greater London
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London, Greater London, Det Forenede Kongerige, EC1A 7BE
- St Bartholomews Hospital - Barts Health /ID# 283714
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Hampshire
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Portsmouth, Hampshire, Det Forenede Kongerige, PO6 3LY
- Queen Alexandra Hospital /ID# 281839
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North Lanarkshire
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Airdrie, North Lanarkshire, Det Forenede Kongerige, ML6 0JS
- NHS Lanarkshire /ID# 282021
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Nottinghamshire
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Nottingham, Nottinghamshire, Det Forenede Kongerige, NG5 1PB
- Nottingham City Hospital /ID# 282748
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Arizona
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Tucson, Arizona, Forenede Stater, 85704
- University of Arizona Cancer Center /ID# 285339
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California
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Cerritos, California, Forenede Stater, 90703
- Toi Clinical Research - Whittier /ID# 284462
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Los Angeles, California, Forenede Stater, 90095-3075
- University of California Los Angeles /ID# 282444
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Colorado
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Aurora, Colorado, Forenede Stater, 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, Forenede Stater, 20007
- MedStar Georgetown University Hospital /ID# 283734
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Florida
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Weston, Florida, Forenede Stater, 33331
- Cleveland Clinic Florida /ID# 283692
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
- Northwest Georgia Oncology Centers /ID# 284769
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center /ID# 283095
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center /ID# 285204
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 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, Forenede Stater, 10029
- The Mount Sinai Hospital /ID# 283535
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center /ID# 283510
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medicine - Cornell University /ID# 283712
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center /ID# 283480
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center /ID# 283475
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Novant Health Forsyth Medical Center /ID# 283485
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center /ID# 283527
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University /ID# 282023
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- SCRI Oncology Partners /ID# 281380
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Texas
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Houston, Texas, Forenede Stater, 77030-4000
- MD Anderson Houston /ID# 282622
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute /ID# 283512
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospitals and Clinics /ID# 282516
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrig, 06202
- Chu de Nice-Hopital Larchet Ii /Id# 283541
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrig, 37044
- CHRU Tours - Hopital Bretonneau /ID# 281925
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrig, 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, Frankrig, 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, Frankrig, 84000
- Centre Hospitalier d'Avignon /ID# 283509
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South Holland
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Leiden, South Holland, Holland, 2333 ZA
- Leids Universitair Medisch Centrum /ID# 283142
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Rotterdam, South Holland, Holland, 3015 CE
- Erasmus Medisch Centrum /ID# 283408
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italien, 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, Norge, 5021
- Haukeland University Hospital /ID# 283524
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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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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Maranon /ID# 283342
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Hospital Universitario Marques de Valdecilla /ID# 283344
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Clinica Universidad de Navarra - Pamplona /ID# 283290
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Kaohsiung City, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital /ID# 282970
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Universitaetsklinikum Freiburg /ID# 282874
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Karlsruhe, Baden-Wurttemberg, Tyskland, 76133
- Staedtisches Klinikum Karlsruhe /ID# 283569
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Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Universitaetsklinikum Tuebingen /ID# 282873
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Ulm, Baden-Wurttemberg, Tyskland, 89081
- Universitaetsklinikum Ulm /ID# 283884
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Bavaria
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Würzburg, Bavaria, Tyskland, 97080
- Universitaetsklinikum Wuerzburg /ID# 283572
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Lower Saxony
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Hanover, Lower Saxony, Tyskland, 30459
- Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Tyskland, 53127
- Universitaetsklinikum Bonn /ID# 283881
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Cologne, North Rhine-Westphalia, Tyskland, 50937
- Universitaetsklinikum Koeln /ID# 283930
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Vas County
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Szombathely, Vas County, Ungarn, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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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Eksperimentel: 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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Aktiv komparator: 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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Indsprøjtning
Indsprøjtning
Oral or Injection
Injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety Run-In: Number of Participants With Adverse Events (AE)s
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Tidsramme: 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.
|
Up to Approximately 75 Months
|
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Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Neoplasmer
- Tilbagevenden
- Myelomatose
- Polycykliske forbindelser
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Dexamethason
- carfilzomib
- Pomalidomid
- Daratumumab
Andre undersøgelses-id-numre
- M22-538
- 2026-525596-11-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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