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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 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

520

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Medicamento: Etentamig
Injection
Medicamento: Pomalidomide
Oral
Experimental: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Medicamento: Etentamig
Injection
Medicamento: Pomalidomide
Oral
Comparador Ativo: 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.
Medicamento: Daratumumabe
Injeção
Medicamento: Carfilzomibe
Injeção
Medicamento: Dexamethasone
Oral or Injection
Medicamento: Teclistamab
Injection

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Safety Run-In: Number of Participants With Adverse Events (AE)s
Prazo: 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
Prazo: 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
Prazo: Up to Approximately 75 Months
PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.
Up to Approximately 75 Months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Prazo: 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
Prazo: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Time to Cmax (Tmax) of Etentamig
Prazo: 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
Prazo: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Immunogenicity of Etentamig
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Up to Approximately 75 Months
Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 FACT-G GP5. Patient-reported outcome (PRO) assessment.
Up to Approximately 75 Months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AbbVie

Investigadores

  • Diretor de estudo: ABBVIE INC., AbbVie

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de novembro de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2033

Conclusão do estudo (Estimado)

1 de fevereiro de 2033

Datas de inscrição no estudo

Enviado pela primeira vez

22 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de julho de 2026

Primeira postagem (Real)

27 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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