Belantamab mafodotin, lenalidomide, and dexamethasone for intermediate-fit and frail patients with newly diagnosed myeloma.

Clinical Snapshot

Key Findings

• P Value: Not provided in abstract

• Effect Size: 18-month progression-free survival: 83.0%; 18-month time to progression: 97.2%

• Primary Outcome: Overall response rate: 97.6%

• Nnt Or Sensitivity: Cannot calculate NNT without control group; response rate suggests approximately 1 in 1 patients will respond

• Confidence Interval: Not provided in abstract

Clinical Application

Requires belantamab mafodotin availability and ophthalmologic monitoring infrastructure, though hematologist-led assessment may reduce specialist requirements Relevant for Australian practice given aging population and high proportion of transplant-ineligible myeloma patients. Would require TGA approval and PBS listing for accessibility. Aligns with current RACGP guidelines emphasising individualised care for frail elderly patients Transplant-ineligible patients with newly diagnosed multiple myeloma, particularly intermediate-fit and frail elderly patients

Abstract

The phase 1/2 BelaRd (belantamab mafodotin [belamaf], lenalidomide, and dexamethasone) study evaluated the efficacy and safety of 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 1.9 mg/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 grade ≥3 OAEs. Among the RP2D patients (n = 42), overall response rate was 97.6%, median progression-free survival (PFS)/overall survival have not been reached yet, and the 18-month PFS and time to progression 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 reinfusion was 13 weeks. Overall, BelaRd is an effective regimen for transplant-ineligible patients with NDMM and warrants a phase 3 study in this setting. OAEs' impact on quality of life appears limited, and implementation of the hematologist-led VRA tool may eventually reduce the necessity for ophthalmologist assessments. This trial was registered at www.clinicaltrials.gov as #NCT04808037.

References

1. 1.Terpos, E., Gavriatopoulou, M., Ntanasis-Stathopoulos, I., Malandrakis, P., Fotiou, D., Kanellias, N., Migkou, M., Theodorakakou, F., Spiliopoulou, V., Solia, E., Eleutherakis-Papaiakovou, E., Psarros, G., Kastritis, E., & Dimopoulos, M. A. (2026). Belantamab mafodotin, lenalidomide, and dexamethasone for intermediate-fit and frail patients with newly diagnosed myeloma. Blood. https://doi.org/10.1182/blood.2025031629