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Can a new injection outperform standard care for a rare protein disease?

NCT ID NCT07793422

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This phase 3 trial compares an investigational drug called etentamig against a standard combination therapy (daratumumab, cyclophosphamide, bortezomib, and dexamethasone) in people newly diagnosed with AL amyloidosis, a rare disease where abnormal proteins build up in organs. About 370 participants will receive either etentamig or the standard regimen. Researchers will measure how well each treatment controls the disease, delays organ failure, and affects quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etentamig (ABBV-383), an investigational drug given by injection
What this could lead to
If etentamig works better than the standard combination, it could become a new first-line treatment for AL amyloidosis, potentially slowing organ damage and improving survival.
What could go wrong
This is an early-stage comparison in a rare disease, and etentamig may not prove more effective or safe than existing therapy. Side effects and treatment burden could be higher.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 370 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

AL amyloidosis amyloidosis Immunoglobulin Light-chain Amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloid light chain (AL) amyloidosis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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