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Amyloid Light Chain (AL) AmyloidosisPhase 3NCT07793422

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

A Phase 3 study testing Etentamig, Daratumumab and Cyclophosphamide in people with Amyloid Light Chain (AL) Amyloidosis, run by AbbVie.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloid Light Chain (AL) Amyloidosis
What is being tested?
Etentamig, Daratumumab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
No sites listed yet
Study dates
29 Nov 2026to Dec 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

About this study

Official title: 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.

Read more

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.

Keywords
Amyloid Light Chain Amyloidosis, Newly Diagnosed AL Amyloidosis, Etentamig, ABBV-383, VCd
Medical subject headings
Amyloidosis, Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07793422
Study groupRoleWhat they receive
Safety Run-in: EtentamigExperimentalParticipants receive etentamig, as part of a 96 month study duration.
Receives: Drug: Etentamig
Randomized Portion: EtentamigExperimentalParticipants will receive etentamig , as part of a 96 month study duration.
Receives: Drug: Etentamig
Daratumumab + Cyclophosphamide + Bortezomib + DexamethasoneActive comparatorParticipants 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..
Receives: Drug: Daratumumab; Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

    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.

    Measured: Up to Approximately 96 Months

  2. Randomized Portion: Complete Hematologic Response (HemeCR) Rate

    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)

    Measured: Up to Approximately 60 Months

  3. Randomized Portion: Major Organ Deterioration Progression-Free Survival (MOD-PFS)

    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.

    Measured: Up to Approximately 60 Months

Secondary outcomes (27)

  1. Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)

    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.

    Measured: Up to Approximately 60 Months

  2. Safety Run-In and Randomized Portion: Overall Survival (OS)

    Overall survival defined as the time from randomization to death from any cause.

    Measured: Up to Approximately 60 Months

  3. Safety Run-In and Randomized Portion: Percentage of Participants With Hematologic Very Good Partial Response (VGPR) or Better

    Percentage of participants achieving hematologic very good partial response or better based on International Amyloidosis Consensus Criteria.

    Measured: Up to Approximately 60 Months

  4. Safety Run-In and Randomized Portion: Cardiac Response Rate

    Percentage of participants achieving cardiac response as assessed per graded criteria.

    Measured: Up to Approximately 60 Months

  5. Safety Run-In and Randomized Portion: Renal Response Rate

    Percentage of participants achieving renal response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.

    Measured: Up to Approximately 60 Months

  6. Safety Run-In and Randomized Portion: Liver Response Rate

    Percentage of participants achieving liver response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.

    Measured: Up to Approximately 60 Months

  7. Safety Run-In and Randomized Portion: Time to Next Treatment

    Time from randomization to initiation of next anti-AL amyloidosis treatment.

    Measured: Up to Approximately 60 Months

  8. Safety Run-In and Randomized Portion: Time to Complete Hematologic Response

    Time from randomization to first documentation of complete hematologic response (hemeCR) as determined by International Amyloidosis Criteria Committee.

    Measured: Up to Approximately 60 Months

  9. Safety Run-In and Randomized Portion: Duration of Complete Hematologic Response

    Duration of complete hematologic response (hemeCR) defined as the time from first documentation of hemeCR to the date of loss of hemeCR.

    Measured: Up to Approximately 60 Months

  10. Randomized Portion: Time to Cardiac Response

    Time from randomization to first achievement of cardiac response.

    Measured: Up to Approximately 60 Months

  11. Safety Run-In and Randomized Portion: Time to Renal Response

    Time from randomization to first achievement of renal response.

    Measured: Up to Approximately 60 Months

  12. Safety Run-In and Randomized Portion: Time to Liver Response

    Time from randomization to first achievement of liver response.

    Measured: Up to Approximately 60 Months

  13. Safety Run-In and Randomized Portion: Duration of Cardiac Response

    Time from first achievement of cardiac response to cardiac progression.

    Measured: Up to Approximately 60 Months

  14. Safety Run-In and Randomized Portion: Duration of Renal Progression

    Time from first achievement of renal response to renal progression.

    Measured: Up to Approximately 60 Months

  15. Safety Run-In and Randomized Portion: Duration of Liver Response

    Time from first achievement of liver response to liver progression.

    Measured: Up to Approximately 60 Months

  16. Safety Run-In and Randomized Portion: Time to Cardiac Progression

    Time from randomization to first occurrence of cardiac progression.

    Measured: Up to Approximately 60 Months

  17. Safety Run-In and Randomized Portion: Time to Renal Progression

    Time from randomization to first occurrence of renal progression.

    Measured: Up to Approximately 60 Months

  18. Safety Run-In and Randomized Portion: Time to Liver Progression

    Time from randomization to first occurrence of liver progression.

    Measured: Up to Approximately 60 Months

  19. Safety Run-In and Randomized Portion: Maximum Serum Concentration (Cmax) of Etentamig

    Cmax of etentamig.

    Measured: Up to Approximately 60 Months

  20. Safety Run-In and Randomized Portion: Time to Maximum Serum Concentration (Tmax) of Etentamig

    Tmax of etentamig.

    Measured: Up to Approximately 60 Months

  21. Safety Run-In and Randomized Portion: Area Under the Concentration-Time Curve (AUC) of Etentamig

    AUC of etentamig.

    Measured: Up to Approximately 60 Months

  22. Safety Run-In and Randomized Portion: Percentage of Participants With Anti-Drug Antibodies (ADA)

    Immunogenicity assessed through summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antidrug antibodies (NAbs), if NAbs samples are analyzed.

    Measured: Up to Approximately 60 Months

  23. 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

    The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.

    Measured: Up to Approximately 60 Months

  24. Randomized Portion: Change from Baseline in Mental Functioning as Measured by SF-36 v2 Mental Component Summary Score

    The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.

    Measured: Up to Approximately 60 Months

  25. 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

    The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.

    Measured: Up to Approximately 60 Months

  26. Randomized Portion: Change from Baseline in Fatigue as Measured by EORTC QLQ-C30 Fatigue Scale Score

    The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.

    Measured: Up to Approximately 60 Months

  27. Randomized Portion: Change from Baseline in Disease Symptoms as Measured by Additional EORTC Questionnaire Symptom Scales/Items

    The EORTC questionnaires assess cancer-specific symptoms and quality of life.

    Measured: Up to Approximately 60 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start29 Nov 2026 (estimated)
  3. Primary completionDec 2034 (estimated)
  4. Study completionDec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793422
Sponsor's protocol ID
M24-473
Other IDs
2026-525253-37-00
Status last verified
Aug 2026
First submitted
26 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etentamig, Daratumumab and Cyclophosphamide in people with Amyloid Light Chain (AL) Amyloidosis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Up to Approximately 96 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07793422.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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