
In a phase 3 trial (AQUILA, NCT03301220), subcutaneous daratumumab monotherapy was evaluated against active monitoring in 390 patients with high-risk smoldering multiple myeloma. With a median follow-up of 65.2 months, daratumumab reduced the risk of disease progression or death by 51% (HR: 0.49, P<0.001), with 5-year progression-free survival rates of 63.1% vs. 40.8% in the monitoring group. Overall survival at 5 years was higher in the daratumumab group (93.0% vs. 86.9%). Adverse events were manageable, with hypertension being the most common grade 3 or 4 event (5.7% in the daratumumab group). These findings support daratumumab as an effective treatment to delay progression in high-risk smoldering multiple myeloma.
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