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AQUILA showed that treating high-risk smouldering myeloma with the antibody daratumumab, rather than waiting for it to turn into active disease, delayed that progression, making it the first drug shown in a randomised trial to hold back myeloma before it causes symptoms.
AQUILA was an open-label phase 3 trial in patients with smouldering multiple myeloma judged high risk by disease burden and biomarkers. Patients were randomised to subcutaneous daratumumab monotherapy for up to 39 cycles or three years, or to active monitoring, the standard of care.
Daratumumab significantly prolonged progression-free survival, defined as progression to active myeloma by SLiM-CRAB criteria or death, the primary endpoint. It was the first phase 3 trial of a monoclonal antibody in this precursor state and led to approval of daratumumab for high-risk smouldering myeloma in the United States in 2025. The earlier E3A06 trial had shown a similar effect with lenalidomide but without a survival benefit; how to define high risk well enough to justify treatment remains the live question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
390 enrolled.
Median follow-up 65.2 months
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 5 years (progression to active myeloma or death)primary | Subcutaneous daratumumab | 194 | 63.1% | 0.49 (0.36 to 0.67) | <0.001 | link |
| Active monitoring | 196 | 40.8% | ||||
| Overall survival at 5 years | Subcutaneous daratumumab | 194 | 93% | 0.52 (0.27 to 0.98) | - | link |
| Active monitoring | 196 | 86.9% |
Shares Daratumumab, Johnson & Johnson, Monoclonal antibodies, Multiple myeloma and the tag subtype-trials.
Shares Daratumumab, Johnson & Johnson, Monoclonal antibodies, Multiple myeloma and the tag subtype-trials.
Shares Daratumumab, Johnson & Johnson, Monoclonal antibodies, Multiple myeloma and the tag subtype-trials.
Shares Johnson & Johnson and the tag subtype-trials.
Shares Johnson & Johnson and the tag subtype-trials.
Shares Monoclonal antibodies and the tag subtype-trials.
Shares Monoclonal antibodies and the tag subtype-trials.
Shares Monoclonal antibodies and the tag subtype-trials.