S300: HEALTH-RELATED QUALITY OF LIFE IN TRANSPLANT-INELIGIBLE REAL-LIFE MULTIPLE MYELOMA PATIENTS TREATED WITH BORTEZOMIB-MELPHALAN-PREDNISONE (VMP) VS. LENALIDOMIDE-DEXAMETHASONE (RD)

Background: Multiple Myeloma (MM) is a chronic disease, and patients (pts) receive long-lasting treatment. Thus, the impact on health-related quality of life (HRQoL) may be burdensome, especially in elderly pts. Bortezomib-melphalan-prednisone (VMP) and lenalidomide-dexamethasone (Rd) represented standard-of-care treatments for transplant-ineligible (NTE) newly diagnosed (ND)MM pts before the introduction of daratumumab upfront. No prospective data are available comparing HRQoL in pts receiving VMP vs Rd in a randomized fashion. Aims: We conducted an analysis of Patient Reported Outcomes (PROs) in the context of a randomized multicenter phase IV trial (Real MM Trial, NCT03829371; funded by the Italian Medicines Agency AIFA - Independent Research), to compare HRQoL differences associated with VMP vs Rd treatment in an unselected real-life MM population. Methods: NTE NDMM pts were randomized to receive 9 VMP cycles vs continuous Rd according to standard practice. Pts gave written informed consent and were enrolled regardless of performance status, comorbidities, renal function, or baseline laboratory values. PROs were collected and analyzed using the validated EORTC QLQ-C30 scales and the EQ-5D-5L visual analog scale (VAS) instruments. PROs were collected at baseline, every 3 months during the first year, and every 6 months thereafter. The PROs analyses included pts from the interim analysis (median follow-up: 14.0 months) who had at least a baseline and a follow-up questionnaire available. Data through month 12 are reported. Change in HRQoL from baseline in VMP vs Rd pts was analyzed in a linear mixed model adjusted for International Myeloma Working Group (IMWG) frailty score and cytogenetic risk. Results are presented as least squares (LS) mean change from baseline. Results: At the data cut-off (17-12-2021), 104 pts (56 in the VMP arm and 48 in the Rd arm) had available PROs and were eligible for the analysis. Overall, 46% of pts had >75 years and 40% were frail. No differences in terms of baseline characteristics and response rates were found in the VMP vs Rd arms. Mean baseline values of PROs reflected the deep impairment of pts’ HRQoL at MM diagnosis and were similar in the two arms. After the start of treatment, the different QLQ-C30 scales were analyzed. Global Health Status (GHS) was significantly worse with VMP vs Rd at 3 months (-3.3 vs +9.0; P=0.002), while from the 6-month time point onwards no differences can be found due to an improvement in GHS in the VMP arm (Figure). The physical functioning scale was worse in the VMP vs Rd arm at 3 (-7.8 vs +0.04; P=0.070) and 6 months (-8.2 vs +3.2; P=0.013), with no differences in later time points. The role functioning scale behaved similarly (-5.9 vs +5.2 at 3 months with VMP vs Rd; P=0.038). VMP also increased fatigue (+9.4 vs -2.7; P=0.015), nausea (+8.6 vs +2.8; P=0.04), and appetite loss (+12.0 vs -3.0; P=0.007) at 3 months, with an improvement in the symptoms thereafter. In both arms, pain decreased after treatment. No clear differences in the other QLQ-C30 scales were observed. The EQ-5D-5L VAS scale showed a significantly worse score in the VMP vs Rd arm at 3 months (-7.9 vs +1.7; P=0.005) and at 12 months (-0.6 vs +10.3; P=0.017). Image:Summary/Conclusion: A comparison of PROs in real-life NTE NDMM pts treated with VMP vs Rd showed a worse HRQoL in the VMP arm early in the treatment course that improved thereafter. At 3 months, after treatment start, VMP was associated with worse GHS, physical functioning, role functioning, fatigue, nausea, appetite loss, and EQ-5D-5L VAS scores.