What type of study is this?

This is a Pre-Registered Trial study.

December 8, 2025Blood

Cardiac risk factors and cardiac events in patients with newly diagnosed amyloid light chain (AL) amyloidosis from the Phase 2 aquarius study of daratumumab (DARA) plus bortezomib, cyclophosphamide, and dexamethasone (D-VCd)

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Phase 2 study shows cardiac events in AL amyloidosis patients treated with daratumumab and dexamethasone, indicating manageable safety profiles.

Cardiac events were similar across treatment regimens for AL amyloidosis patients, suggesting consistent safety.
Complete Response rates were comparable: 62.1% for immediate vs 59.0% for deferred treatment.
Primary safety endpoints for cardiac treatment emergent adverse events were assessed using echocardiogram and HS TroponinT.
Major cardiac events primarily linked to underlying disease severity, highlighting the importance of monitoring baseline risk factors.

Rosenzweig et al. (2025) studied this question.

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December 8, 2025Blood

View Full Paper

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Authors

Phase 2 study shows cardiac events in AL amyloidosis patients treated with daratumumab and dexamethasone, indicating manageable safety profiles.

Cardiac events were similar across treatment regimens for AL amyloidosis patients, suggesting consistent safety.
Complete Response rates were comparable: 62.1% for immediate vs 59.0% for deferred treatment.
Primary safety endpoints for cardiac treatment emergent adverse events were assessed using echocardiogram and HS TroponinT.
Major cardiac events primarily linked to underlying disease severity, highlighting the importance of monitoring baseline risk factors.

Rosenzweig et al. (2025) studied this question.

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