Faster and sustained improvement in health-related quality of life (HRQoL) for newly diagnosed multiple myeloma (NDMM) patients ineligible for transplant treated with daratumumab, lenalidomide, and dexamethasone (D-Rd) versus Rd alone: MAIA.

person Aurore Perrot Department of Hematology, University Hospital, Vandoeuvre-Lès-Nancy, France info_outline Aurore Perrot, Thierry Facon, Torben Plesner, Saad Zafar Usmani, Shaji Kumar, Nizar J. Bahlis, Karthik Ramasamy, Murielle Roussel, Carla Araujo, Arnaud Jaccard, Michel Delforge, Caroline McKay, Katharine Gries, Jeremiah Trudeau, Cyrille Hulin, Katja Weisel

Authors person Aurore Perrot Department of Hematology, University Hospital, Vandoeuvre-Lès-Nancy, France info_outline Aurore Perrot, Thierry Facon, Torben Plesner, Saad Zafar Usmani, Shaji Kumar, Nizar J. Bahlis, Karthik Ramasamy, Murielle Roussel, Carla Araujo, Arnaud Jaccard, Michel Delforge, Caroline McKay, Katharine Gries, Jeremiah Trudeau, Cyrille Hulin, Katja Weisel Organizations Department of Hematology, University Hospital, Vandoeuvre-Lès-Nancy, France, Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, Vejle Hospital and University of Southern Denmark, Vejle, Denmark, Levine Cancer Institute/Atrium Health, Charlotte, NC, Department of Hematology, Mayo Clinic Rochester, Rochester, MN, University of Calgary, Arnie Charbonneau Cancer Research Institute, Calgary, AB, Canada, Oxford University Hospital and NIHR BRC Blood Theme, Oxford, United Kingdom, CHU Purpan/IUCT Oncopole, Toulouse, France, Centre Hospitalier de la Côte Basque, Bayonne, France, Centre Hospitalier Universitaire, Limoges, France, Department of Hematology, University Hospital Leuven, Leuven, Belgium, Janssen Global Services, Raritan, NJ, Department of Hematology, Hospital Haut Leveque, University Hospital Bordeaux, Pessac, France, Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: MAIA, an ongoing phase 3 trial of transplant-ineligible patients (pts) with NDMM, demonstrated significant improvement in progression-free survival with D-Rd vs Rd alone. Assessment of pt-reported outcomes alongside efficacy endpoints provides pt perspective on their quality of survival and overall value of HRQoL while on treatments (tx). Methods: The EORTC QLQ-C30 and EQ-5D-5L questionnaires were completed by pts using an electronic device at baseline and every 3 mo during tx; interim results are presented for first 12 mo. Tx effects were assessed using repeated measures, mixed effects models and thresholds for clinically meaningful benefit were based on established criterion from the literature. Results: Compliance rates were high and comparable at baseline ( > 90%) and through month 12 ( > 80%) for both groups (D-Rd [n = 368]; Rd [n = 369]). Improvement in Global Health Status (GHS) occurred in both groups; however, for D-Rd, significantly greater improvement was observed at cycle 3 (LS mean change; D-Rd: 4.5 [95% CI: 2.4, 6.6], Rd: 1.5 [95% CI: -0.7, 3.7]; [p = 0.0454]) and increasing improvement occurred across all time points. Significant improvement and clinically meaningful benefit in HRQoL for D-Rd was also observed in EQ-5D-5L Visual Analog Scale (VAS) scores (LS mean change; D-Rd: 10.1 [95% CI: 8.1, 12.1], Rd: 4.9 [95% CI: 2.8, 7.0]; [p = 0.0002]). The VAS median time to worsening was 10 mo longer for D-Rd. Of note, meaningful differences were observed between the tx groups in two subscale scores, pain symptoms and cognitive functioning. Statistically significant less pain was reported early with D-Rd (LS mean change at cycle 3; D-Rd: -17.9 [95% CI: -20.7, -15.0], Rd: -11.0 [95% CI: -14.0, -8.1]; [p = 0.0007]); clinically meaningful reduction in pain symptoms was sustained with D-Rd. There was a decline in cognitive functioning at cycle 12 in both tx arms, with no statistically significant differences between groups. Conclusions: Faster and sustained improvement in HRQoL was observed in pts treated with D-Rd vs Rd with similar findings reflected across pain subscale. Clinical trial information: NCT02252172