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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 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

370

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Safety Run-in: Etentamig
Participants receive etentamig, as part of a 96 month study duration.
Droga: Etentamig
Injection
Experimental: Randomized Portion: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
Droga: Etentamig
Injection
Comparador activo: 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..
Droga: Daratumumab
Inyección
Droga: Dexametasona
Oral
Droga: Cyclophosphamide
Oral
Droga: Bortezomib
Injection
Droga: Bortezomib
Infusion
Droga: Cyclophosphamide
Infusion
Droga: Dexamethasone
Infusion

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Adverse Events
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to Approximately 60 Months
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
Up to Approximately 60 Months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AbbVie

Investigadores

  • Director de estudio: ABBVIE INC., AbbVie

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

29 de noviembre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2034

Finalización del estudio (Estimado)

1 de diciembre de 2034

Fechas de registro del estudio

Enviado por primera vez

26 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de agosto de 2026

Publicado por primera vez (Actual)

28 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M24-473
  • 2026-525253-37-00 (Ctis)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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