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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. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

520

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Legemiddel: Etentamig
Injection
Legemiddel: Pomalidomide
Oral
Eksperimentell: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Legemiddel: Etentamig
Injection
Legemiddel: Pomalidomide
Oral
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.
Legemiddel: Daratumumab
Injeksjon
Legemiddel: Carfilzomib
Injeksjon
Legemiddel: Dexamethasone
Oral or Injection
Legemiddel: Teclistamab
Injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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.
Up to Approximately 75 Months
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).
Up to Approximately 75 Months
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
Tiltaksbeskrivelse
Tidsramme
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
Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Tidsramme: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Time to Cmax (Tmax) of Etentamig
Tidsramme: 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
Tidsramme: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
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.
Up to Approximately 75 Months
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.
Up to Approximately 75 Months
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.
Up to Approximately 75 Months
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).
Up to Approximately 75 Months
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AbbVie

Etterforskere

  • Studieleder: ABBVIE INC., AbbVie

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. november 2026

Primær fullføring (Antatt)

1. februar 2033

Studiet fullført (Antatt)

1. februar 2033

Datoer for studieregistrering

Først innsendt

22. juli 2026

Først innsendt som oppfylte QC-kriteriene

22. juli 2026

Først lagt ut (Faktiske)

27. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere