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Perrot, A.1; Facon, T.2; Plesner, T.3; Usmani, S. Z.4; Kumar, S.5; Orlowski, R. Z.6; Bahlis, N. J.7; Nahi, H.8; Mollee, P.9; Ramasamy, K.10; Roussel, M.11; Chaleteix, C.12; Araujo, C.13; Jaccard, A.14; Delforge, M.15; Karlin, L.16; Arnulf, B.17; Chari, A.18; Wang, J.19; Kobos, R.19; McKay, C.20; Gries, K. S.20; Trudeau, J.20; Hulin, C.21; Weisel, K.22

doi: 10.1097/01.HS9.0000560700.97828.31
Poster Session I: Myeloma and other monoclonal gammopathies - Clinical

1Hematology Department, University Hospital, Vandoeuvre Les Nancy

2Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France

3Vejle Hospital and University of Southern Denmark, Vejle, Denmark

4Levine Cancer Institute/Atrium Health, Charlotte, NC

5Department of Hematology, Mayo Clinic Rochester,, Rochester, MN

6Department of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, United States

7University of Calgary, Arnie Charbonneau Cancer Research Institute, Calgary, AB, Canada

8Karolinska Institute, Department of Medicine, Division of Hematology, Karolinska University Hospital at Huddinge, Stockholm, Sweden

9Princess Alexandra Hospital and University of Queensland, Brisbane, Australia

10Oxford University Hospital and NIHR BRC Blood Theme, Oxford, United Kingdom

11CHU Purpan/IUCT Oncopole, Toulouse

12Centre Hospitalier Universitaire, Clermont Ferrand

13Centre Hospitalier de la Côte Basque, Bayonne

14Centre Hospitalier Universitaire, Limoges, France

15Department of Hematology, University Hospital Leuven, Leuven, Belgium

16Centre Hospitalier Lyon-Sud Hematologie (HCL), Pierre - Benite Cedex

17Hematology/Oncology, Hopital Saint Louis, Paris, France

18Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY

19Janssen Research & Development

20Janssen Global Services, Raritan, NJ, United States

21Department of Hematology, Hospital Haut Leveque, University Hospital, Pessac, France

22Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

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MAIA, an ongoing phase 3 trial of transplant-ineligible patients with NDMM, demonstrated significant improvement in progression-free survival with D-Rd vs Rd alone. Assessment of patient-reported outcomes (PRO) alongside efficacy endpoints provides patient perspective on their quality of survival and overall value of health-related quality of life (HRQoL) while on treatments.

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To utilize PRO assessments as a tool in capturing the patient perspective on quality of survival and HRQoL changes in MAIA.

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The EORTC QLQ-C30 and EQ-5D-5L questionnaires were completed by patients using an electronic device at baseline and every 3 months during treatment; interim results are presented for first 12 months. Treatment effects were assessed using repeated measures, mixed effects models and thresholds for clinically meaningful benefit were based on established criterion from the literature.

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Compliance rates in completing the assessment tools 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 treatment 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 through Cycle 12 in both treatment arms with the peak difference occurring at Cycle 9, but mean differences between groups were not statistically significant.

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Faster and sustained improvement in patients treated with D-Rd was observed using HRQoL assessments compared with Rd, with similar findings reflected across the pain subscale.

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.