Adding the anti-CD38 agent daratumumab (Darzalex) to cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) improved the rate of hematologic complete response and delayed the time to major organ deterioration progression-free survival (MOD-PFS) compared with CyBorD in patients with newly diagnosed light chain (AL) amyloidosis who were enrolled in the phase III ANDROMEDA study.
The primary endpoint, hematologic complete response rate as assessed by a blinded review committee, was achieved by 53% of patients randomized to the D-CyBorD regimen compared with 18% of those assigned to CyBorD without daratumumab (OR 5.1, 95% CI 3.2-8.2, P<0.0001), with a median duration of follow-up of 11.4 months, reported Efstathios Kastritis, MD, during the virtual program of the European Hematology Association.
