Study summary

Treating high-risk smoldering myeloma early with daratumumab halved progression and improved survival

AQUILA trial · 390 people, phase 3 · Published December 2024, New England Journal of Medicine; FDA approved November 2025

63.1%progression-free at 5 years, vs 40.8% with monitoring

What was tested

Subcutaneous daratumumab, a CD38 antibody, given for up to 3 years, against active monitoring, for high-risk smoldering multiple myeloma (no symptoms or organ damage yet).

What they found

What it means

The first approved treatment for smoldering myeloma, changing the long-standing "watch and wait" rule for high-risk people.

N Engl J Med, via PubMed ↗ ← Back to the outlook
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