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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 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

370

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Safety Run-in: Etentamig
Participants receive etentamig, as part of a 96 month study duration.
Lek: Etentamig
Injection
Eksperymentalny: Randomized Portion: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
Lek: Etentamig
Injection
Aktywny komparator: 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..
Lek: Daratumumab
Zastrzyk
Lek: Deksametazon
Doustny
Lek: Cyclophosphamide
Oral
Lek: Bortezomib
Injection
Lek: Bortezomib
Infusion
Lek: Cyclophosphamide
Infusion
Lek: Dexamethasone
Infusion

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Adverse Events
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Up to Approximately 60 Months
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
Up to Approximately 60 Months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AbbVie

Śledczy

  • Dyrektor Studium: ABBVIE INC., AbbVie

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

29 listopada 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2034

Ukończenie studiów (Szacowany)

1 grudnia 2034

Daty rejestracji na studia

Pierwszy przesłany

26 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

28 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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