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 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
370
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Safety Run-in: Etentamig
Participants receive etentamig, as part of a 96 month study duration.
|
Injection
|
|
Experimentell: Randomized Portion: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
|
Injection
|
|
Aktiv 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..
|
Injektion
Oral
Oral
Injection
Infusion
Infusion
Infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Adverse Events
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to Approximately 60 Months
|
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
|
Up to Approximately 60 Months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: ABBVIE INC., AbbVie
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
29 november 2026
Primärt slutförande (Beräknad)
1 december 2034
Avslutad studie (Beräknad)
1 december 2034
Studieregistreringsdatum
Först inskickad
26 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
26 augusti 2026
Första postat (Faktisk)
28 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Metaboliska sjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Neoplasmer, Plasmacell
- Paraproteinemier
- Proteostasbrister
- Närings- och metabola sjukdomar
- Immunoglobulin lättkedjig amyloidos
- Amyloidos
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Kolväten
- Polycykliska föreningar
- Oorganiska kemikalier
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Steroider, fluorerade
- Fosforamidsen
- Kväve senapsföreningar
- Senapsföreningar
- Kolväten, halogenerad
- Fosforamider
- Organofosforföreningar
- Graviditet
- Borrsyror
- Syror, icke -karboxyl
- Syror
- Boreföreningar
- Pyraziner
- Bortezomib
- Dexametason
- Cyklofosfamid
- daratumumab
Andra studie-ID-nummer
- M24-473
- 2026-525253-37-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Kriterier för IPD Sharing Access
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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