Skip to content
Bending the Curve Trial by Trial
?

AQUILA

Daratumumab or active monitoring for high-risk smoldering multiple myeloma

Phase 3N = 390NCT03301220

Population
Patients with high-risk smoldering multiple myeloma
Design
Phase 3 randomised trial of subcutaneous daratumumab monotherapy versus active monitoring. Daratumumab was continued for 39 cycles, for 36 months, or until confirmed disease progression, whichever occurred first. Progression to active multiple myeloma was assessed by an independent review committee according to IMWG diagnostic criteria.
Primary endpoint
PFS
Arms
  • Subcutaneous daratumumab (experimental, n = 194): Subcutaneous daratumumab monotherapy for up to 39 cycles or 36 months
  • Active monitoring (control, n = 196): Active monitoring
People
Dimopoulos MA
PFSHR 0.49 (95% CI 0.36–0.67)Δ 60-month PFS+22.3 pointsOSHR 0.52 (95% CI 0.27–0.98)Δ 60-month OS+6.1 points
Show the numbers
Results reported for AQUILA
EndpointAnalysisSubcutaneous daratumumabActive monitoringEffect
PFSEnrolled patients (390)Progression to active multiple myeloma assessed by an independent review committee according to IMWG diagnostic criteria, or deathprimarymedian follow-up 65.2 monthsDimopoulos 202563.1% at 5 y40.8% at 5 yHR 0.49 (95% CI 0.36–0.67)P<0.001Hazard ratio for disease progression or death. Landmark values are the 5-year progression-free survival rates in the abstract.
OSEnrolled patients (390)primarymedian follow-up 65.2 monthsDimopoulos 202593% at 5 y86.9% at 5 yHR 0.52 (95% CI 0.27–0.98)Hazard ratio for death (15 deaths, 7.7%, in the daratumumab group; 26 deaths, 13.3%, with active monitoring). No p-value is given in the abstract.
Results reported for AQUILA
EndpointAnalysisSubcutaneous daratumumabActive monitoringEffect
PFSEnrolled patients (390)Progression to active multiple myeloma assessed by an independent review committee according to IMWG diagnostic criteria, or deathprimarymedian follow-up 65.2 monthsDimopoulos 202563.1% at 5 y40.8% at 5 yHR 0.49 (95% CI 0.36–0.67)P<0.001Hazard ratio for disease progression or death. Landmark values are the 5-year progression-free survival rates in the abstract.
OSEnrolled patients (390)primarymedian follow-up 65.2 monthsDimopoulos 202593% at 5 y86.9% at 5 yHR 0.52 (95% CI 0.27–0.98)Hazard ratio for death (15 deaths, 7.7%, in the daratumumab group; 26 deaths, 13.3%, with active monitoring). No p-value is given in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.490.36–0.67
OS0.520.27–0.98
Primary publication: Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, et al. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. N Engl J Med. 2025;392(18):1777-1788. PubMedDOI

Appears in

Sources

  1. Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, et al. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. N Engl J Med. 2025;392(18):1777-1788.

    PubMedDOI