Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis

26 de agosto de 2026 atualizado por: AbbVie

A Phase 3 Multicenter, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) Compared to Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (Dara-CyBorD) in Subjects With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis

Amyloid light chain (AL) amyloidosis is a rare disease caused by abnormal plasma cells producing misfolded light chain proteins that deposit in organs, leading to organ dysfunction and failure. The goal of this study is to evaluate the safety and efficacy of etentamig compared to daratumumab plus cyclophosphamide plus bortezomib plus dexamethasone (Dara-CyBorD) in participants with newly diagnosed AL amyloidosis.

Etentamig is an investigational drug being developed for the treatment of newly diagnosed AL amyloidosis. This is an open-label study. The study consists of 2 parts: a Safety Run-in where participatns will receive etentamig, and a Randomized Portion with 2 treatment arms where participants will receive etentamig, or Dara-CyBorD. Approximately 370 participants will be enrolled in the study at approximately 130 sites worldwide.

Participants will receive injected etentamig, in the Safety Run-in. Participants will receive injected etentamig, or Dara-CyBorD per the local label, in the Randomized Portion of the study. The total study duration is approximately 96 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)

370

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

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:

  • Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red-stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance.
  • Evidence of a monoclonal plasma cell proliferative disorder (serum or urine monoclonal protein, abnormal free light-chain ratio, or clonal plasma cells in the bone marrow).
  • Measurable disease of amyloid light chain (AL) amyloidosis as defined by difference in free light chains (dFLC) >= 50 mg/L
  • No history of treatment with anti-amyloidosis therapy.
  • Presence of an amyloid-related systemic syndrome with at least 1 organ impacted by AL amyloidosis according to International Myeloma Working Group (IMWG) diagnostic criteria.
  • Considered AL amyloidosis cardiac risk stage 1, 2, or 3a (or 3b [randomized portion only]).
  • Eastern Cooperative Oncology Group performance status <= 2.

Exclusion Criteria:

  • Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatments.
  • Active hepatitis B or hepatitis C infection.
  • History of other active malignancies within the past 3 years (with specified exceptions).

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 sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Safety Run-in: Etentamig
Participants receive etentamig, as part of a 96 month study duration.
Medicamento: Etentamig
Injection
Experimental: Randomized Portion: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
Medicamento: Etentamig
Injection
Comparador Ativo: Daratumumab + Cyclophosphamide + Bortezomib + Dexamethasone
Participants will receive daratumumab plus cyclophosphamide plus bortezomib plus dexamethasone (Dara-CyBorD) in accordance with the local approved label, as part of a 96 month study duration..
Medicamento: Daratumumabe
Injeção
Medicamento: Dexametasona
Oral
Medicamento: Cyclophosphamide
Oral
Medicamento: Bortezomib
Injection
Medicamento: Bortezomib
Infusion
Medicamento: Cyclophosphamide
Infusion
Medicamento: Dexamethasone
Infusion

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Adverse Events
Prazo: Up to Approximately 96 Months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety and tolerability assessed through adverse events, laboratory tests, vital signs, physical examinations, and other safety assessments.
Up to Approximately 96 Months
Randomized Portion: Complete Hematologic Response (HemeCR) Rate
Prazo: Up to Approximately 60 Months
HemeCR rate is defined as the proportion of subjects with the best overall response of hemeCR as determined by International Amyloidosis Consensus Criteria (IACC) and assessed by the independent review committee (IRC)
Up to Approximately 60 Months
Randomized Portion: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Prazo: Up to Approximately 60 Months
MOD-PFS is defined as the time from the date of randomization to the date of MOD-PFS event or death from any cause, whichever occurs first. MOD-PFS includes: Development of hematologic progressive disease per consensus guidelines or high-risk difference in free light chain (dFLC) progression; Clinical manifestation of cardiac failure (defined as need for cardiac transplant, left ventricular assist device, or intra-aortic balloon pump); Clinical manifestation of renal failure (defined as development of end-stage renal disease needing hemodialysis or renal transplant); Death. MOD-PFS will be assessed by an Independent Review Committee.
Up to Approximately 60 Months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Prazo: Up to Approximately 60 Months
MOD-PFS is defined as the time from the date of randomization to the date of MOD-PFS event or death from any cause, whichever occurs first. MOD-PFS includes: Development of hematologic progressive disease per consensus guidelines or high-risk difference in free light chain (dFLC) progression; Clinical manifestation of cardiac failure (defined as need for cardiac transplant, left ventricular assist device, or intra-aortic balloon pump); Clinical manifestation of renal failure (defined as development of end-stage renal disease needing hemodialysis or renal transplant); Death.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Overall Survival (OS)
Prazo: Up to Approximately 60 Months
Overall survival defined as the time from randomization to death from any cause.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Percentage of Participants With Hematologic Very Good Partial Response (VGPR) or Better
Prazo: Up to Approximately 60 Months
Percentage of participants achieving hematologic very good partial response or better based on International Amyloidosis Consensus Criteria.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Cardiac Response Rate
Prazo: Up to Approximately 60 Months
Percentage of participants achieving cardiac response as assessed per graded criteria.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Renal Response Rate
Prazo: Up to Approximately 60 Months
Percentage of participants achieving renal response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Liver Response Rate
Prazo: Up to Approximately 60 Months
Percentage of participants achieving liver response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Next Treatment
Prazo: Up to Approximately 60 Months
Time from randomization to initiation of next anti-AL amyloidosis treatment.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Complete Hematologic Response
Prazo: Up to Approximately 60 Months
Time from randomization to first documentation of complete hematologic response (hemeCR) as determined by International Amyloidosis Criteria Committee.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Complete Hematologic Response
Prazo: Up to Approximately 60 Months
Duration of complete hematologic response (hemeCR) defined as the time from first documentation of hemeCR to the date of loss of hemeCR.
Up to Approximately 60 Months
Randomized Portion: Time to Cardiac Response
Prazo: Up to Approximately 60 Months
Time from randomization to first achievement of cardiac response.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Renal Response
Prazo: Up to Approximately 60 Months
Time from randomization to first achievement of renal response.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Liver Response
Prazo: Up to Approximately 60 Months
Time from randomization to first achievement of liver response.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Cardiac Response
Prazo: Up to Approximately 60 Months
Time from first achievement of cardiac response to cardiac progression.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Renal Progression
Prazo: Up to Approximately 60 Months
Time from first achievement of renal response to renal progression.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Liver Response
Prazo: Up to Approximately 60 Months
Time from first achievement of liver response to liver progression.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Cardiac Progression
Prazo: Up to Approximately 60 Months
Time from randomization to first occurrence of cardiac progression.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Renal Progression
Prazo: Up to Approximately 60 Months
Time from randomization to first occurrence of renal progression.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Liver Progression
Prazo: Up to Approximately 60 Months
Time from randomization to first occurrence of liver progression.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Maximum Serum Concentration (Cmax) of Etentamig
Prazo: Up to Approximately 60 Months
Cmax of etentamig.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Maximum Serum Concentration (Tmax) of Etentamig
Prazo: Up to Approximately 60 Months
Tmax of etentamig.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Area Under the Concentration-Time Curve (AUC) of Etentamig
Prazo: Up to Approximately 60 Months
AUC of etentamig.
Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Percentage of Participants With Anti-Drug Antibodies (ADA)
Prazo: Up to Approximately 60 Months
Immunogenicity assessed through summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antidrug antibodies (NAbs), if NAbs samples are analyzed.
Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Physical Functioning as Measured by 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary Score
Prazo: Up to Approximately 60 Months
The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.
Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Mental Functioning as Measured by SF-36 v2 Mental Component Summary Score
Prazo: Up to Approximately 60 Months
The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.
Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score
Prazo: Up to Approximately 60 Months
The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.
Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Fatigue as Measured by EORTC QLQ-C30 Fatigue Scale Score
Prazo: Up to Approximately 60 Months
The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.
Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Disease Symptoms as Measured by Additional EORTC Questionnaire Symptom Scales/Items
Prazo: Up to Approximately 60 Months
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
Up to Approximately 60 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)

29 de novembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2034

Conclusão do estudo (Estimado)

1 de dezembro de 2034

Datas de inscrição no estudo

Enviado pela primeira vez

26 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de agosto de 2026

Primeira postagem (Real)

28 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • M24-473
  • 2026-525253-37-00 (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

Não

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 .

Se inscrever