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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Amyloid light chain (AL) amyloidosis is a rare disease caused by abnormal plasma cellsproducing misfolded light chain proteins that deposit in organs, leading to organdysfunction and failure. The goal of this study is to evaluate the safety and efficacy ofetentamig compared to daratumumab plus cyclophosphamide plus bortezomib plusdexamethasone (Dara‐CyBorD) in participants with newly diagnosed AL amyloidosis.Etentamig is an investigational drug being developed for the treatment of newly diagnosedAL amyloidosis. This is an open‐label study. The study consists of 2 parts: a SafetyRun‐in where participatns will receive etentamig, and a Randomized Portion with 2treatment arms where participants will receive etentamig, or Dara‐CyBorD. Approximately370 participants will be enrolled in the study at approximately 130 sites worldwide.Participants will receive injected etentamig, in the Safety Run‐in. Participants willreceive injected etentamig, or Dara‐CyBorD per the local label, in the Randomized Portionof the study. The total study duration is approximately 96 months.There may be higher treatment burden for participants in this trial compared to theirstandard of care due to study procedures. Participants will attend regular visits duringthe study at a hospital or clinic. The effects of the treatment will be checked bymedical assessments, blood tests, checking for side effects and completingquestionnaires.
Epistemonikos ID: b9c07fb480da554894ecf66bb3351b23c9f55a8c
First added on: Aug 29, 2026