P-164: Reduction in Disease Symptoms/Impacts After Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone Treatment for Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma (GRIFFIN Study)

Introduction: In the final analysis of the phase 2 randomized GRIFFIN study after all patients (pts) completed 1 year of follow-up post maintenance therapy, died or withdrew (median follow-up, 49.6 months), daratumumab (dara), lenalidomide (R), bortezomib and dexamethasone (D-RVd) led to a clinically meaningful progression-free survival benefit vs RVd (hazard ratio, 0.45; 95% CI, 0.21–0.95; P=0.032). Patient-reported outcome (PRO) data also showed that D-RVd pts who continued on maintenance treatment experienced greater improvements in health-related quality of life vs RVd alone. Here, we present item-level responses from the PRO instruments to understand the degree of change after treatment (tx) on singular concepts.

Methods: Transplant-eligible (TE) pts with newly diagnosed multiple myeloma (NDMM) were randomized 1:1 to receive 4 D-RVd/RVd induction cycles, autologous stem cell transplant (ASCT), 2 D-RVd/RVd consolidation cycles, and up to 2 years’ maintenance therapy with R ± dara. PRO data were collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30), EORTC QLQ Multiple Myeloma Module 20-item (EORTC QLQ-MY20), and EuroQol 5-level (EQ-5D-5L) tools. Questionnaires were completed at baseline, on day 1 of cycles (C) 2, 3, 5; on day 21 of C4; post ASCT consolidation (C6 D21); and after months 6, 12, 18, and 24 of maintenance. Frequency distribution, by tx group and by visit, were summarized for PRO items reporting on MM disease symptoms and functional impacts.

Results: A total of 207 pts were randomized (D-RVd, n=104; RVd, n=103). For both D-RVd/DR and RVd/R, pts reported a reduction in disease symptoms and impacts; when questioned on the presence of these symptoms/impacts, a greater proportion answered “not at all/a little” during maintenance vs “quite a bit/very much” at baseline. For rigorous activities and disease-specific symptoms including hip pain, trouble taking a long walk, and need to rest, a higher proportion of pts in the D-RVd/DR vs the RVd/R arm reported no symptom/impact during maintenance. For example, for trouble taking a long walk, a similar proportion of pts reported “not at all” at baseline for D-RVd/DR versus RVd/R (31.8% vs 29.8%, respectively), but a greater proportion of D-RVd/DR pts reported “not at all” at maintenance month 6 (45.3% vs 37.2%), 12 (44.6% vs 37.1%), 18 (37.2% vs 33.3%), and 24 (50.0% vs 43.5%). There were no differences in pts responding “not at all” between D-RVd/DR and RVd/R for pain in back, arm/shoulder, or chest; being tired; pain interfering with activities; and limitations of usual activities.

Conclusions: The addition of dara to RVd/R in TE pts with NDMM led to meaningful reductions in disease symptoms/impact, with a higher proportion of D-RVd/DR pts reporting no symptom/impact after tx on items related to pain in hip, trouble taking a long walk, and needing to rest, compared to RVd/R.