Understanding the AQUILA Study Design in High-Risk Smoldering Multiple Myeloma

This segment provides an overview of the AQUILA phase 3 trial design and the key methodological considerations that informed its development. Faculty review the global, randomized study structure comparing fixed-duration subcutaneous daratumumab with active monitoring in patients with high-risk smoldering multiple myeloma.

The discussion highlights critical design elements, including patient eligibility criteria, the fixed-duration dosing schedule, and the selection of progression-free survival as the primary end point. Panelists explore how these choices were intended to address limitations of earlier studies by enabling a more definitive assessment of clinical benefit over long-term follow-up.

By examining the rationale behind the trial design, this segment helps contextualize the efficacy and safety results that follow and frames how AQUILA sought to balance rigorous data generation with real-world feasibility in an asymptomatic patient population.