BACKGROUND: In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. METHODS: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. RESULTS: Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. CONCLUSIONS: Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02195479 , registered September 21, 2014.

Andrew Love Cancer Centre Geelong Australia

Azienda Ospedaliera Santa Maria Terni Italy

Champalimaud Centre for the Unknown Lisbon Portugal

Clinic of Professional Pathology Saratov Russia

Clinica de Tratamento E Cuiaba Brazil

Clínica Universidad de Navarra Centro de Investigación Médica Aplicada Instituto de Investigación Sanitaria de Navarra Centro de Investigación Biomédica en Red de Cáncer Pamplona Spain

Department of Haematology and Oncology Würzburg University Medical Center Oberdürrbacher Straße 6 97080 Würzburg Germany

Department of Internal Medicine Seoul National University College of Medicine Seoul Republic of Korea

Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4 Dnipropetrovsk Ukraine

Institute of Hematology Department of Experimental Diagnostic and Specialty Medicine University of Bologna Bologna Italy

Janssen Research and Development LLC Spring House PA USA

Janssen Research and Development Raritan NJ USA

Japanese Red Cross Medical Center Tokyo Japan

Leicester Royal Infirmary Leicester UK

LTD Medinvent Institute of Health Tbilisi Georgia

Matsuyama Red Cross Hospital Matsuyama Japan

National and Kapodistrian University of Athens Athens Greece

Semmelweis University Budapest Hungary

Silesian Medical University Katowice Poland

Université Catholique of Louvain CHU UCL Namur Yvoir Belgium

University Hospital Brno Brno Czech Republic

University Hospital of Salamanca Instituto de Investigación Biomédica de Salamanca Salamanca Spain

University Hospitals Birmingham NHS Trust Birmingham UK

University of Chicago Medical Center Chicago IL USA

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ClinicalTrials.gov
NCT02195479