MM-510 Patient-Reported Outcomes in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) Treated With Belantamab Mafodotin (Belamaf) Versus Pomalidomide Plus Low-Dose Dexamethasone (Pd) in the DREAMM-3 Study

• Published in: Clinical lymphoma, myeloma and leukemia myeloma and leukemia, 2023-09, Vol.23, p.S505-S505
• Main Authors: Hungria, Vania, Weisel, Katja, Currie, Brooke, Perera, Sue, Sule, Neal, He, Wei, Davy, Katherine, McKeown, Astrid, Sapra, Sandhya, Nelsen, Linda, Li, Mary, Barale, Sophie, Boyle, Julia, McPoyle, Kaytlyn, Dimopoulos, Meletios Athanasios
• Format: Article
• Language: English
• Subjects: belantamab mafodotin; multiple myeloma; phase III; relapsed/refractory multiple myeloma
• ISSN: 2152-2650; 2152-2669
• DOI: 10.1016/S2152-2650(23)01463-5

The phase III DREAMM-3 trial (NCT04162210) evaluated single-agent belamaf versus Pd in adults with RRMM at second relapse or later. Evaluate changes in disease symptoms, health-related quality of life, and patient-reported tolerability of belamaf versus Pd in DREAMM-3. Patients were randomized (2:1) to receive belamaf or Pd and completed electronic patient-reported outcome (PRO) tools at baseline and every 3 weeks: European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; fatigue, physical functioning, global health); EORTC Myeloma Module (EORTC QLQ-MY20; disease–specific pain); Ocular Surface Disease Index (OSDI; vision-related functioning [VRF]); PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE; symptomatic tolerability); and Functional Assessment of Cancer Therapy GP5 (FACT-GP5; treatment bother). Mean EORTC changes from baseline were assessed. In 287 patients (belamaf, n=192; Pd, n=95), PRO assessment compliance was ≈75% to 90% in both groups across visits. The belamaf group reported small mean improvements from baseline in fatigue, with significantly greater improvements versus Pd at weeks 13, 19, and 40. There were no significant between-group differences in mean scores for other EORTC domains. Mean global health status and physical functioning scores were stable/improved throughout the study for both groups, with belamaf demonstrating increasingly larger improvements from week 37. Both groups reported small mean improvements in disease pain from baseline. VRF deterioration was observed by week 7 with belamaf: 67% of patients had ≥1 meaningful deterioration event (Pd, 49%); 31% reported ≥1 instance of “severe” or “very severe” blurred vision (Pd, 8%). Apart from this, both treatments were well tolerated; >80% of patients in both groups reported no/mild/infrequent adverse events (AEs) at each visit. Most patients in each group (>70%) reported feeling “not at all” or “a little” bothered by treatment side effects across visits. Patients receiving belamaf versus Pd showed larger fatigue improvements; small improvements in MM-associated pain were seen in both groups. Despite ocular AEs, physical functioning and global health status for patients on belamaf improved over time. These data show belamaf is a well-tolerated treatment option with a positive impact on health outcomes, particularly fatigue, for patients with RRMM.