OA – 13: Belantamab mafodotin, pomalidomide, and dexamethasone vs pomalidomide, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma: patient-reported outcomes from DREAMM-8

Introduction: Belantamab mafodotin (belamaf) is a first-in-class antibody-drug conjugate targeting B-cell maturation antigen and acts through a multimodal mechanism. The phase 3, open-label, randomized DREAMM-8 trial (NCT04484623) met its primary endpoint of a statistically significant progression-free survival (PFS) benefit favoring belamaf, pomalidomide, and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma (RRMM) who had received ≥1 prior therapy, including lenalidomide. Here, we present patient-reported outcomes (PROs) with BPd vs PVd.


Methods: Patients were randomized (1:1) to BPd or PVd. Patients completed PRO assessments at baseline and every 4 weeks (Q4W) during treatment, and at a reduced frequency beyond this. PRO measures included EORTC QLQ-C30, EORTC QLQ-MY20/IL52 disease symptoms/pain, PRO-CTCAE patient-reported tolerability, FACT-GP5 side effects, and OSDI (Q8W after week 21). Based on the median PFS of 12.7 months with PVd, this analysis focused on the time points within the first year of data collection (up to week 53). Each domain was summarized using descriptive statistics.


Results: Among 302 patients (BPd, n=155; PVd, n=147), adherence to PRO assessments until treatment discontinuation was >90% for most visits up to week 53. EORTC QLQ-C30 global health status/quality of life (GHS/QOL), role and physical functioning, fatigue, and pain were maintained over time in both the BPd and PVd arms overall. Between weeks 5 and 53, patients receiving BPd or PVd maintained overall QOL (< 10-point change from baseline), as measured by the EORTC QLQ-C30 GHS/QOL domain, and there were no differences (≥10 points) between treatment arms. Similarly, there were no differences (≥10 points) between treatment arms for physical functioning, fatigue, role functioning, or disease symptoms/pain. A higher proportion of patients reported vision-related function (≥12.5-point increase from baseline) and ocular symptom (≥16.67-point increase from baseline) worsening on BPd vs PVd as reported on the OSDI measure. However, this improved for most patients; median time to improvement in vision-related function from the first meaningful worsening was 57.0 days. Most symptomatic adverse events evaluated by PRO-CTCAE were reported as no to low severity, frequency, and interference (PRO-CTCAE ratings ≤2) in both arms throughout the study. Blurred vision and fatigue were reported at higher levels (PRO-CTCAE ratings ≥3) in the BPd arm. As measured by the FACT-GP5, most patients in the BPd arm (generally 84%-98%) reported feeling “not at all,” “a little bit,” or “somewhat” bothered by treatment side effects; a similar pattern was observed in the PVd arm (89%-100%).


Conclusions: Treatment with BPd or PVd in patients with RRMM resulted in stable health-related QOL over time and was generally well tolerated by patients.