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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

22. července 2026 aktualizováno: AbbVie

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

520

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Austrálie
    • New South Wales
      • Wollongong, New South Wales, Austrálie, 2500
        • Wollongong Hospital. /ID# 282694
    • Queensland
      • Benowa, Queensland, Austrálie, 4217
        • Pindara Private Hospital /ID# 283010
      • South Brisbane, Queensland, Austrálie, 4101
        • Icon Cancer Care - South Brisbane /ID# 282965
    • Victoria
      • Melbourne, Victoria, Austrálie, 3000
        • Peter MacCallum Cancer Centre. /ID# 282692
      • Richmond, Victoria, Austrálie, 3121
        • Epworth Hospital - Richmond /ID# 281877
    • Western Australia
      • Murdoch, Western Australia, Austrálie, 6150
        • Fiona Stanley Hospital /ID# 281879
      • Nedlands, Western Australia, Austrálie, 6009
        • Sir Charles Gairdner Hospital /ID# 281881
  • Francie
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Francie, 06202
        • Chu de Nice-Hopital Larchet Ii /Id# 283541
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Francie, 37044
        • CHRU Tours - Hopital Bretonneau /ID# 281925
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Francie, 54511
        • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, Francie, 44000
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
    • Provence-Alpes-Côte d'Azur Region
      • Avignon, Provence-Alpes-Côte d'Azur Region, Francie, 84000
        • Centre Hospitalier d'Avignon /ID# 283509
  • Holandsko
    • South Holland
      • Leiden, South Holland, Holandsko, 2333 ZA
        • Leids Universitair Medisch Centrum /ID# 283142
      • Rotterdam, South Holland, Holandsko, 3015 CE
        • Erasmus Medisch Centrum /ID# 283408
  • Itálie
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Itálie, 47014
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
  • Kanada
    • British Columbia
      • Victoria, British Columbia, Kanada, V8R 6V5
        • British Columbia Cancer Agency Vancouver Centre /ID# 282147
    • Ontario
      • London, Ontario, Kanada, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
  • Maďarsko
    • Vas County
      • Szombathely, Vas County, Maďarsko, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
  • Norsko
    • Sogn Og Fjordane
      • Bergen, Sogn Og Fjordane, Norsko, 5021
        • Haukeland University Hospital /ID# 283524
  • Německo
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Německo, 79106
        • Universitaetsklinikum Freiburg /ID# 282874
      • Karlsruhe, Baden-Wurttemberg, Německo, 76133
        • Staedtisches Klinikum Karlsruhe /ID# 283569
      • Tübingen, Baden-Wurttemberg, Německo, 72076
        • Universitaetsklinikum Tuebingen /ID# 282873
      • Ulm, Baden-Wurttemberg, Německo, 89081
        • Universitaetsklinikum Ulm /ID# 283884
    • Bavaria
      • Würzburg, Bavaria, Německo, 97080
        • Universitaetsklinikum Wuerzburg /ID# 283572
    • Lower Saxony
      • Hanover, Lower Saxony, Německo, 30459
        • Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Německo, 53127
        • Universitaetsklinikum Bonn /ID# 283881
      • Cologne, North Rhine-Westphalia, Německo, 50937
        • Universitaetsklinikum Koeln /ID# 283930
  • Portugalsko
      • Braga, Portugalsko, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 283828
      • Porto, Portugalsko, 4200-319
        • Unidade Local de Saude Sao Joao /ID# 283530
    • Lisbon District
      • Lisbon, Lisbon District, Portugalsko, 1449-005
        • Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugalsko, 4434-502
        • Unidade Local de Saude de Gaia/Espinho /ID# 283492
  • Spojené království
    • Devon
      • Plymouth, Devon, Spojené království, PL6 8DH
        • University Hospitals Plymouth NHS Trust /ID# 283108
    • Edinburgh, City of
      • Edinburgh, Edinburgh, City of, Spojené království, EH4 2XU
        • Western General Hospital - NHS Lothian /ID# 281838
    • Greater London
      • London, Greater London, Spojené království, EC1A 7BE
        • St Bartholomews Hospital - Barts Health /ID# 283714
    • Hampshire
      • Portsmouth, Hampshire, Spojené království, PO6 3LY
        • Queen Alexandra Hospital /ID# 281839
    • North Lanarkshire
      • Airdrie, North Lanarkshire, Spojené království, ML6 0JS
        • NHS Lanarkshire /ID# 282021
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Spojené království, NG5 1PB
        • Nottingham City Hospital /ID# 282748
  • Spojené státy
    • Arizona
      • Tucson, Arizona, Spojené státy, 85704
        • University of Arizona Cancer Center /ID# 285339
    • California
      • Cerritos, California, Spojené státy, 90703
        • Toi Clinical Research - Whittier /ID# 284462
      • Los Angeles, California, Spojené státy, 90095-3075
        • University of California Los Angeles /ID# 282444
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • University Of Colorado - Anschutz Medical Campus /ID# 283478
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20007
        • MedStar Georgetown University Hospital /ID# 283734
    • Florida
      • Weston, Florida, Spojené státy, 33331
        • Cleveland Clinic Florida /ID# 283692
    • Georgia
      • Marietta, Georgia, Spojené státy, 30060
        • Northwest Georgia Oncology Centers /ID# 284769
    • Illinois
      • Chicago, Illinois, Spojené státy, 60612
        • Rush University Medical Center /ID# 283095
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02215
        • Beth Israel Deaconess Medical Center /ID# 285204
    • Michigan
      • Grand Rapids, Michigan, Spojené státy, 49503
        • Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
    • New York
      • New York, New York, Spojené státy, 10029
        • The Mount Sinai Hospital /ID# 283535
      • New York, New York, Spojené státy, 10032
        • Columbia University Medical Center /ID# 283510
      • New York, New York, Spojené státy, 10065
        • Weill Cornell Medicine - Cornell University /ID# 283712
      • Rochester, New York, Spojené státy, 14642
        • University of Rochester Medical Center /ID# 283480
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27599
        • University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University Medical Center /ID# 283475
      • Winston-Salem, North Carolina, Spojené státy, 27103
        • Novant Health Forsyth Medical Center /ID# 283485
    • Ohio
      • Cleveland, Ohio, Spojené státy, 44106
        • University Hospitals Cleveland Medical Center /ID# 283527
    • Oregon
      • Portland, Oregon, Spojené státy, 97239
        • Oregon Health and Science University /ID# 282023
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37203
        • SCRI Oncology Partners /ID# 281380
    • Texas
      • Houston, Texas, Spojené státy, 77030-4000
        • MD Anderson Houston /ID# 282622
    • Utah
      • Salt Lake City, Utah, Spojené státy, 84112
        • Huntsman Cancer Institute /ID# 283512
    • Virginia
      • Richmond, Virginia, Spojené státy, 23298
        • VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
    • Wisconsin
      • Madison, Wisconsin, Spojené státy, 53792
        • University of Wisconsin Hospitals and Clinics /ID# 282516
  • Tchaj-wan
      • Kaohsiung City, Tchaj-wan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 282970
  • Španělsko
      • Madrid, Španělsko, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 283342
    • Cantabria
      • Santander, Cantabria, Španělsko, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 283344
    • Navarre
      • Pamplona, Navarre, Španělsko, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 283290

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Lék: Etentamig
Injection
Lék: Pomalidomide
Oral
Experimentální: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Lék: Etentamig
Injection
Lék: Pomalidomide
Oral
Aktivní komparátor: 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.
Lék: Daratumumab
Injekce
Lék: Carfilzomib
Injekce
Lék: Dexamethasone
Oral or Injection
Lék: Teclistamab
Injection

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Safety Run-In: Number of Participants With Adverse Events (AE)s
Časové okno: 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.
Up to Approximately 75 Months
Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
Časové okno: 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).
Up to Approximately 75 Months
Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Časové okno: 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
Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Časové okno: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Time to Cmax (Tmax) of Etentamig
Časové okno: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig
Časové okno: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Immunogenicity of Etentamig
Časové okno: 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.
Up to Approximately 75 Months
Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AbbVie

Vyšetřovatelé

  • Ředitel studie: ABBVIE INC., AbbVie

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. listopadu 2026

Primární dokončení (Odhadovaný)

1. února 2033

Dokončení studie (Odhadovaný)

1. února 2033

Termíny zápisu do studia

První předloženo

22. července 2026

První předloženo, které splnilo kritéria kontroly kvality

22. července 2026

První zveřejněno (Aktuální)

27. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • M22-538
  • 2026-525596-11-00 (Ctis)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Časový rámec sdílení IPD

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Kritéria přístupu pro sdílení IPD

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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