The BENEFIT trial

Prof Dr Nathalie Meuleman, haematologist at the Institut Jules Bordet in Brussels summarized the outcomes of the BENEFIT trial presented at EHA 2024

CD38-targeting immunotherapy, in combination with lenalidomide and dexamethasone, is currently approved for the treatment of newly diagnosed, transplant-ineligible multiple myeloma (NDMM TI) and is considered the standard of care (SOC). To enhance the existing SOC, the potential benefit of extending the use of bortezomib over 18 months with a reduced intensity weekly schedule added to IsaRd was evaluated. The objective was to assess the impact of incorporating a proteasome inhibitor into a quadruplet regimen on improving the depth of response.

The BENEFIT trial is a prospective, multicenter, randomized, parallel study involving patients aged 65-79 years who are non-frail and diagnosed with NDMM TI. This trial compares the efficacy and safety of the IsaRd regimen versus the Isa-VRd regimen. The primary endpoint, MRD 10-5 at 18 months from the start of treatment was significantly higher in the Isa-VRd arm compared to the IsaRd arm. The safety profile is consistent with the addition of bortezomib. The inclusion of a weekly, “light” bortezomib schedule did not significantly impact the relative dose intensity of the IsaRd regimen.

These findings suggest that the Isa-VRd regimen should be considered a new standard of care for non-frail patients with NDMM TI.