What question did this study set out to answer?

This research aims to assess the safety, tolerability, and clinical efficacy of belantamab mafodotin combined with lenalidomide and dexamethasone in newly diagnosed myeloma patients.

April 19, 2026Open Access

B06 | Belantamab Mafodotin Plus Lenalidomide/Dexamethasone in Newly Diagnosed Intermediate-Fit and Frail Multiple Myeloma: Long-Term Efficacy and Safety From the Phase 1/2 Belard Clinical Trial

Key Points

This research aims to assess the safety, tolerability, and clinical efficacy of belantamab mafodotin combined with lenalidomide and dexamethasone in newly diagnosed myeloma patients.
Phase 1/2 open-label study targeting transplant ineligible newly diagnosed myeloma patients.
Evaluated safety and established a recommended dose of 1.9 mg/kg every 8 weeks.
Part 2 randomized patients to receive dose modifications based on different assessment tools for ocular adverse events.
Overall response rate was high at 97.6%, with significant depths of response including complete responses.
Median progression-free survival at 18 months was 82.9% and at 24 months was 74.9%.
Minimal vision-related activity impacts were observed, supporting the ocular safety of the treatment approach.

Abstract

Background. The aim of this study was to evaluate safety, tolerability, and clinical activity of belamaf plus lenalidomide and dexamethasone (Rd) (BelaRd) in transplant ineligible newly diagnosed myeloma (TI-NDMM) patients (pts).Methods. BelaRd trial (NCT04808037) was a phase 1/2, open label study in frail and intermediate-fit pts with NDMM In part 1 (n=36), we evaluated the safety/tolerability of belamaf 2.5/1.9/1.4 mg/kg every 8 weeks (Q8W) plus Rd and we established a recommended phase 2 dose (RP2D) of 1.9 mg/kg Q8W. In Part 2, pts (n=30) were treated at RP2D and randomized 1:1 to Group (Gr) A (dose modification guided by ophthalmologist-assessed KVA scale) or Gr B (hematologist-led Vision-Related Anamnestic (VRA) tool with ophthalmologist assessment focused on grade 3 ≥ ocular adverse events, OAEs). Results. To-date, 42 pts overall (part 1, n=12; part 2, n=30) received belamaf at the RP2D with Rd. Median follow up was 38.4 months (range 13.2-44.1) in part 1 and 19.7 months (range 3.9-26.4) in part 2. Median belamaf exposure was 12 doses in part 1, and 7 doses in part 2. Median dose intensity was 0.6 mg/kg/Q4W in both parts, with median relative dose intensity of 59.4% (range 44.0–89.7) and 51.3% (range 34.1–73.5), respectively. For pts treated at 1.9 mg/kg across both study parts, overall response rate (≥PR) was 97.6% (41/42 pts); 15 pts (35.7%) showed a sCR, 6 pts (14.3%) a CR, 16 pts (38.1%) a VGPR, 4 pts (9.5%) a PR. MRD negativity was achieved in 50% pts (6/12) in part 1, 40% pts (12/30) in part 2. The median time to first response was 1.0 month (range 0.9-3.8) and time to best response was 9.7 months (range 1.0-28.3). Median PFS 7.1%). Grade ≥3 BCVA decline and keratopathy were observed in 54 (13.2%) and 1 (0.3%) of assessments in part 1, and 17 (3.4%) and 1 (0.2%) in part 2, respectively. Grade ≥3 ocular symptoms were observed in 7 pts (58.3%) in part 1 and 9 pts (30%) in part 2. No patient had to discontinue treatment. Conclusions. Belamaf 1.9 mg/kg Q8W with Rd produced rapid, deep responses and durable disease control with a high ORR and high PFS in TI intermediate-fit/frail NDMM patients. Efficacy was maintained with Q8W schedule having minimal impact on vision related daily activities. Overall, hematologist-led VRA strategy reduced dose holds without compromising ocular safety, supporting streamlined monitoring and warranting randomized phase 3 evaluation of Belamaf-Rd. Funding by GSK (NCT04808037); authors solely responsible for content.

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Cite This Study

Terpos et al. (Sun,) studied this question.

synapsesocial.com/papers/69e4702d010ef96374d8d784 https://doi.org/https://doi.org/10.3324/haematol.2026.s2.14094

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