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ASCO 2025 | Long-term outcomes from the BelaRd trial and the evaluation of a VRA tool to guide belamaf dosing
Evangelos Terpos, MD, PhD, University of Athens School of Medicine, Athens, Greece, discusses the results of the BelaRd trial (NCT04808037), a Phase I/II study that investigated a novel, extended dosing schedule of belantamab mafodotin (belamaf) in combination with lenalidomide and dexamethasone (Rd), in transplant-ineligible patients with newly diagnosed multiple myeloma (MM). This combination approach demonstrated promising efficacy, with no new safety signals observed. Prof. Terpos also mentions the evaluation of a Vision-Related Anamnestic (VRA) tool, a patient-reported questionnaire that captures ocular symptoms and their impact on activities of daily living. This VRA tool could aid physicians in making decisions about dosing frequency without the need for an ophthalmology examination. This interview took place at the 11th World Congress on Controversies in Multiple Myeloma (COMy) congress in Paris, France.
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Transcript
This is the Phase I/II study that is going to be followed by a Phase III study because of these results. So what we did in this study, first of all, we evaluated the combination of belantamab mafodotin with lenalidomide and dexamethasone in newly diagnosed patients, but we used it in patients with intermediate fit and frail. We had two parts of the study.
In the first part, we had randomized the patients to receive either 1...
This is the Phase I/II study that is going to be followed by a Phase III study because of these results. So what we did in this study, first of all, we evaluated the combination of belantamab mafodotin with lenalidomide and dexamethasone in newly diagnosed patients, but we used it in patients with intermediate fit and frail. We had two parts of the study.
In the first part, we had randomized the patients to receive either 1.4, 1.9, 2.5 mg per kg given every 8 weeks, in combination with the standard dose of lenalidomide 25 mg and dexamethasone. We checked that the dose in order to go to the second part of the study was the 1.9 mg per kg given every 8 weeks. So we introduced for the first time the administration of belantamab from the beginning every eight weeks. In these 36 patients of the first part of the study, everybody responded. And outside of some deaths that these patients had because of the infections, like COVID-19 especially and I think two pneumonia that we had, during the three-year follow-up, only one patient progressed.
In the second part of the study, 30 more patients received the 1.9 mg per kilogram every eight weeks of belantamab with lenalidomide and dexamethasone and with a randomization according to ocular adverse event. So, in the group A, the patients, let’s say the doctor decide which dose and how often to give based on an ophthalmology evaluation. In the part two, everybody had an ophthalmology evaluation, but also we had a VRA tool, as we call it, an anamnestic tool with questionnaire that the doctors could decide based on that questionnaire, and we wanted to see if there is concordance with the ophthalmology evaluation. So what we’ve seen is, again, we checked that the median PFS of all patients who received this dose of 1.9 mg per kilogram at 18 months was 86%. So, the combination is very efficacious, and we’ve seen that using the VRA tool, the doctors could manage the ocular adverse event very efficiently, and very rarely they had to use the ophthalmology examination, which I think is of extreme importance.
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Disclosures
Advisory Board: Amgen, AstraZeneca, EUSA Pharma, BMS, GSK, J&J, Menarini/Stemline, Pfizer, Sanofi, Takeda; Honoraria: Amgen, Antengene, AstraZeneca, EUSA Pharma, BMS, Forus, GSK, J&J, Menarini/Stemline, Novartis, Pfizer, Sanofi, Swixx, Takeda; Research Funding: Amgen, GSK, J&J, Sanofi, Takeda; Travel Expenses: Takeda.
