Journal of the Advanced Practitioner in Oncology · 15 authors, 8 centres
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In the DREAMM-2 trial, patients with triple-class refractory multiple myeloma treated with belantamab mafodotin 2.5 mg/kg maintained health-related quality of life and functioning despite transient ocular symptoms. Ocular symptoms (e.g., blurred vision, dry eye) peaked at a median of 45–64 days and improved within 23.5–44 days, with most patients recovering. These PRO findings support the use of belantamab mafodotin in this heavily pretreated population.
**Background:** Multiple myeloma (MM) is an incurable hematologic cancer that eventually becomes refractory to treatments. For patients with triple-class refractory relapsed/refractory MM (RRMM), clinical outcomes remain poor. Belantamab mafodotin (belamaf) is a first-in-class BCMA-targeting antibody-drug conjugate that demonstrated deep and durable responses in the phase II DREAMM-2 study. However, it is associated with corneal events (keratopathy) that can cause ocular symptoms. This analysis aimed to describe patient-reported outcomes (PROs) regarding cancer symptoms, tolerability, functioning, and the impact of ocular symptoms in patients receiving the approved 2.5 mg/kg dose.
**Methods:** DREAMM-2 was an open-label, two-arm, randomized, multicenter phase II study. Eligible patients (N=97 for the 2.5 mg/kg arm) had triple-class refractory RRMM, ECOG 0–2, and ≥3 prior lines of therapy. PROs were assessed using validated questionnaires: EORTC-QLQ-C30 (cancer symptoms, functioning, global health status/QOL), EORTC-QLQ-MY20 (myeloma-specific symptoms), Ocular Surface Disease Index (OSDI; ocular symptoms and vision-related functioning), and NEI VFQ-25 (vision-related QOL). Questionnaires were completed at baseline, every 3 or 6 weeks during treatment, and at end of treatment (EOT). Eye examinations (slit lamp, BCVA) were conducted at baseline, before each cycle, and at EOT. Meaningful change thresholds: ≥10 points for EORTC scales, ≥12.5 points for OSDI. Data cutoff: January 31, 2020 (median follow-up 12.4 months).
**Key Results:** Baseline demographics: median age 65 years, median 7 prior therapies (range 3–21), 43% ISS stage III. PRO completion rates were >70% for most visits. EORTC-QLQ-C30: Physical Functioning, Global Health Status/QOL, Fatigue, Role Functioning, and Pain domains were maintained over time. At Week 7, among 46 patients remaining on treatment, 13 improved in Physical Functioning, 21 improved in Fatigue, and 14 improved in Pain; 30, 6, and 19 remained stable, respectively. At Week 25 (n=20), 4 improved in Physical Functioning, 7 in Fatigue, and 4 in Pain; 14, 6, and 9 remained stable. EORTC-QLQ-MY20 Disease Symptoms domain remained stable; at Week 7, 17/45 improved, 18/45 stable, 10/45 worsened. Bone pain improved over time: at Week 31, 8/17 reported no bone pain vs. 18/72 at baseline; 2/17 reported “very much” pain vs. 11/72 at baseline. Ocular PROs (OSDI): Among patients with no/some symptoms at baseline, worsening to “half of the time” or worse occurred in 29/81 for light sensitivity, 30/88 for gritty eyes, 27/89 for painful/sore eyes, 42/83 for blurred vision, and 34/80 for poor vision. Median time to worst severity: 45–64 days. Recovery occurred in 64%–74% of patients; median time to recovery: 23.5–44.0 days. OSDI Vision-Related Functioning worsening (≥12.5 points) occurred in 47/95 patients; median onset 44 days; 34/47 improved (median 24 days). NEI VFQ-25: At baseline, 70/95 reported no/little difficulty driving; at worst-case post-baseline, 37/70 continued with no/little difficulty, 16/70 stopped driving due to eyesight (median onset 63.5 days; 7/16 returned to driving). For reading, 83/95 had no/little difficulty at baseline; at worst-case, 35/83 continued with no/little difficulty, 8/83 stopped reading due to eyesight (7/8 resumed). Among patients with meaningful OSDI Vision-Related Functioning deterioration, EORTC-QLQ-C30 Global Health Status/QOL, Physical Functioning, and Role Functioning scores were maintained similarly to the overall population.
**Clinical Implications:** These PRO data demonstrate that patients with triple-class refractory RRMM treated with belantamab mafodotin 2.5 mg/kg maintained overall HRQOL and functioning despite transient ocular symptoms. Ocular symptoms were generally reversible, with most patients recovering within weeks. The findings support the use of belantamab mafodotin in this heavily pretreated population and highlight the importance of patient counseling regarding expected ocular effects and their temporary nature. The results also suggest that even when vision-related functioning declines, overall QOL and physical functioning are not adversely impacted, which is reassuring for patients and clinicians.