Clinical trial Phase 3 Interventional Ages 18 and up

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

Run by AbbVie · NCT07793422 · Data updated 2026-11-12

Not yet open. This study is not taking new participants. Its registered completion date is 2034-12.

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 …

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment370 (estimated)
SponsorAbbVie
Industry-sponsored
Drugs / interventionsEtentamig, Daratumumab, Cyclophosphamide, Bortezomib, Dexamethasone, Bortezomib, Cyclophosphamide, Dexamethasone
Trial IDNCT07793422 on ClinicalTrials.gov

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.