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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 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

370

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Safety Run-in: Etentamig
Participants receive etentamig, as part of a 96 month study duration.
Droga: Etentamig
Injection
Sperimentale: Randomized Portion: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
Droga: Etentamig
Injection
Comparatore attivo: 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
Iniezione
Droga: Desametasone
Orale
Droga: Cyclophosphamide
Oral
Droga: Bortezomib
Injection
Droga: Bortezomib
Infusion
Droga: Cyclophosphamide
Infusion
Droga: Dexamethasone
Infusion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Approximately 60 Months
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
Up to Approximately 60 Months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie

Investigatori

  • Direttore dello studio: ABBVIE INC., AbbVie

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

29 novembre 2026

Completamento primario (Stimato)

1 dicembre 2034

Completamento dello studio (Stimato)

1 dicembre 2034

Date di iscrizione allo studio

Primo inviato

26 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 agosto 2026

Primo Inserito (Effettivo)

28 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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