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Efficacy and safety of Isa-VRD in the treatment of transplant-ineligible patients with NDMM: Phase III BENEFIT trial
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Data from the phase III BENEFIT trial (NCT04751877) evaluating the impact of the addition of weekly bortezomib to isatuximab, lenalidomide, and dexamethasone (Isa-VRd) for the treatment of transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM) were published by Leleu et al.1 in Nature Medicine. The efficacy and safety of Isa-Rd with and without the addition of bortezomib was evaluated. The primary endpoint was measurable residual disease (MRD) benefit at 18 months post randomization. |
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At 18 months, the MRD negativity rate at ×10-5 was higher in the Isa-VRd arm compared with Isa-Rd arm (53% vs 26%; odds ratio, 3.16; 95% confidence interval, 1.89–5.28; p < 0.0001). |
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Very good partial response and complete response or better was higher with Isa-VRd compared with Isa-Rd (58% vs 31%; odds ratio, 2.97; 95% confidence interval, 2–5; p < 0.0001). |
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Neutropenia was the most common adverse event reported in both cohorts.
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Thrombocytopenia was more frequent in patients treated with Isa-VRd compared with those treated with Isa-Rd (27% vs 14%). |
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Neuropathy was more common in patients treated with Isa-VRd compared with those treated with Isa-Rd (52% vs 28%).
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Isa-VRd demonstrated higher rates of MRD negativity and deeper levels of response, highlighting the potential of Isa-VRd as a new standard of care treatment for transplant-ineligible patients with NDMM. |
- Leleu X, Hulin C, Lambert J, et al. Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial. Nature Medicine. 2024. Online ahead of print. DOI: 1038/s41591-024-03050-2
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