The phase 1/2 BelaRd study (NCT04808037) evaluated the efficacy and safety of belantamab mafodotin (belamaf) combined with lenalidomide and dexamethasone in unfit and frail transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Part 1 (n=36) established a recommended belamaf phase 2 dose (RP2D) of 1.9mg/kg every 8 weeks (median follow-up: 39.3 months). In Part 2, 30 patients were randomized 1:1 in Group A (n=15), where belamaf dosing was guided by ophthalmologist-assessed Ocular Adverse Events (OAEs), whereas in Group B (n=15) belamaf dosing was based on hematologist-led Vision-Related Anamnestic (VRA) tool and ophthalmologist-assessed Gr≥3 OAEs. Among the RP2D patients (n=42), ORR was 97.6%, median PFS/OS have not been reached yet and the 18-month PFS and TTP rates were 83.0% and 97.2%, respectively. Ocular toxicities were similar between assessments by hematologists and ophthalmologists and no ophthalmologist withholding of a hematologist-led dosing occurred. Less than 1% of patients stopped driving/reading because of OAEs. Median time to belamaf re-infusion was 13 weeks. Overall, BelaRd is an effective regimen for transplant-ineligible NDMM patients and warrants a phase 3 study in this setting. OAEs' impact to quality of life appears limited and implementation of the hematologist-led VRA tool may eventually reduce the necessity for ophthalmologist assessments.
Evangelos Eleutherakis‐Papaiakovou (Thu,) studied this question.
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