BACKGROUND: In the phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP) significantly improved progression-free survival (PFS) and overall survival (OS) in transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. We present a subgroup analysis of ALCYONE by patient frailty status. PATIENTS AND METHODS: Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit (0), intermediate (1), or frail (≥2); a nonfrail category combined fit and intermediate patients. RESULTS: Among randomized patients (D-VMP, n = 350; VMP, n = 356), 391 (55.4%) were nonfrail (D-VMP, 187 [53.4%]; VMP, 204 [57.3%]) and 315 (44.6%) were frail (163 [46.6%]; 152 [42.7%]). After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P < .0001), frail (32.9 vs. 19.5 months; HR, 0.51; P < .0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%). Improved greater than or equal to complete response and minimal residual disease (10-5)-negativity rates were observed for D-VMP versus VMP across subgroups. The 2 most common grade 3/4 treatment-emergent adverse events were neutropenia (nonfrail: 39.2% [D-VMP] and 42.4% [VMP]; frail: 41.3% and 34.4%) and thrombocytopenia (nonfrail: 32.8% and 36.9%; frail: 36.9% and 39.1%). CONCLUSION: Our findings support the clinical benefit of D-VMP in transplant-ineligible NDMM patients enrolled in ALCYONE, regardless of frailty status.

Andrew Love Cancer Centre University Hospital Geelong Geelong VIC Australia

Champalimaud Centre for the Unknown Lisbon Portugal

Clinica de Tratamento E Cuiaba Brazil

Clínica Universidad de Navarra Centro de Investigación Médica Aplicada Pamplona Navarra Spain

Department of Hematology and Cancer Prevention in Chorzów Faculty of Health Sciences in Bytom Medical University of Silesia Katowice Poland

Department of Hematology and Oncology Nagoya City University Graduate School of Medical Sciences Mizuho cho Mizuho ku Nagoya Japan

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

Hospital Clínic de Barcelona Institut d'Investigacions Biomèdiques August Pi i Sunyer University of Barcelona Barcelona Spain

IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Istituto di Ematologia Seràgnoli Dipartimento di Medicina Specialistica Diagnostica e Sperimentale Università degli Studi Bologna Italy

Janssen Global Medical Affairs Horsham PA

Janssen Research and Development Beerse Belgium

Janssen Research and Development LLC Raritan NJ

Janssen Research and Development LLC Spring House PA

Janssen Research and Development LLC Titusville NJ

Japanese Red Cross Medical Center Department of Hematology Tokyo Japan

Leicester Royal Infirmary Haematology Leicester United Kingdom

Matsuyama Red Cross Hospital Matsuyama Japan

Medinvest Institute of Hematology Tbilisi Georgia

National and Kapodistrian University of Athens Athens Greece

Semmelweis Egyetem Budapest Hungary

Università degli Studi di Perugia Azienda Ospedaliera Santa Maria Terni Italy

Université Catholique de Louvain Yvoir Belgium

University Hospital Brno Brno Bohunice Brno Starý Lískovec Czech Republic

University Hospital of Salamanca IBSAL Cancer Research Center IBMCC Salamanca Spain

Würzburg University Medical Center Würzburg Germany

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NCT02195479