Health-related quality of life (HRQoL) in patients with relapsed/refractory multiple myeloma (RRMM) receiving real-life current standard of care (SOC) in the LocoMMotion study.

person Michel Delforge University of Leuven, Leuven, Belgium info_outline Michel Delforge, Philippe Moreau, Hermann Einsele, Valerio De Stefano, Joanne Lindsey-Hill, Laure Vincent, Silvia Mangiacavalli, Aurore Perrot, Enrique Ocio, Silene ten Seldam, Ester in ’t Groen-Damen, Maria Semerjian, Vadim Strulev, Jordan Mark Schecter, Tito Roccia, Katharine S. Gries, Tonia Nesheiwat, Robert Wapenaar, Maria-Victoria Mateos, Katja Weisel

Authors person Michel Delforge University of Leuven, Leuven, Belgium info_outline Michel Delforge, Philippe Moreau, Hermann Einsele, Valerio De Stefano, Joanne Lindsey-Hill, Laure Vincent, Silvia Mangiacavalli, Aurore Perrot, Enrique Ocio, Silene ten Seldam, Ester in ’t Groen-Damen, Maria Semerjian, Vadim Strulev, Jordan Mark Schecter, Tito Roccia, Katharine S. Gries, Tonia Nesheiwat, Robert Wapenaar, Maria-Victoria Mateos, Katja Weisel Organizations University of Leuven, Leuven, Belgium, Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France, Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany, Section of Hematology, Catholic University, Fondazione Policlinico A Gemelli, IRCCS, Rome, Italy, Nottinghamshire University Hospitals NHS Trust, Nottingham, United Kingdom, Département d'hématologie Clinique, Centre Hospitalier Universitaire de Montpellier, Montpellier, France, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy, Centre Hospitalier, Universitaire de Toulouse, Service d'Hematologie, Toulouse, France, Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain, Myeloma Patients Europe, Brussels, Belgium, Janssen-Cilag, Breda, Netherlands, Janssen-Cilag, Issy-Les-Moulineaux, France, Janssen Pharmaceutica NV, Beerse, Belgium, Janssen R&D, Raritan, NJ, Janssen Research & Development, High Wycombe, NJ, United Kingdom, Janssen Research & Development, Raritan, NJ, Legend Biotech USA, Piscataway, NJ, University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Pharmaceutical/Biotech Company Background: Evaluation of patient (pt)-reported outcomes provides insight into how real-life SOC treatments (tx) affect HRQoL for pts with RRMM. LocoMMotion (NCT04035226) is the first prospective, multinational study of real-life SOC in triple-class exposed pts with RRMM. Here, we present measures of symptoms, functioning, and overall HRQoL. Methods: LocoMMotion is a prospective, noninterventional study across 76 sites (63 European; 13 US). Pts had received ≥3 prior lines of therapy (LOT) or were refractory to PI and IMiD; received PI, IMiD, and anti-CD38 mAb; and had disease progression during/after last LOT. Real-life SOC tx were defined as those used in local clinical practice. The questionnaires were EORTC QLQ-C30, 4 single items from EORTC QLQ-MY20, and EQ 5D-5L. HRQoL was assessed at baseline (BL), day 1 of each tx cycle, end of tx visit, and during the follow-up period (every 4 weeks). Improvement compared to BL health status was evaluated using established thresholds. Within-group change was assessed using mixed models for repeated measures. Results: Questionnaire completion for pts in the LocoMMotion study (N=248; 54.4% male; median age 68 yrs; median 4.0 [range, 1–20] cycles of SOC) was 75.6% during SOC tx. Most pts did not achieve meaningful improvement in PRO scores, defined by a literature-based minimally important difference of 10 points in mean score. This was most pronounced in pain symptoms (62% of pts had no meaningful improvement during the first 3 months of tx; 55% had no improvement during full tx duration). For the overall population, the least square (LS) mean changes from BL during SOC tx and subsequent LOT are described (Table). Pts who achieved very good partial response and better during SOC tx had greater improvement in PRO scores, including in LS mean change for pain score (-14.9 [95% confidence interval (CI): -22.9, -7.0]). Conclusions: In this first prospective study of real-life current SOC in triple-class exposed pts, limited gains in HRQoL were reported, most notably in pain symptoms. There is an urgent need for effective therapies that can help pts achieve deep responses and delay disease progression, as these are associated with improved HRQoL. Clinical trial information: NCT04035226. LS mean changes from BL. LS mean change from BL (95% CI) During SOC tx N=172 During subsequent tx N=87 Physical functioning a 2.5 (−0.5, 5.5) −11.8 (−17.7, −5.9) Global health status a 1.9 (−1.4, 5.1) −2.0 (−7.1, 3.2) Pain score b −1.4 (−5.8, 2.9) 1.8 (−4.7, 8.3) Fatigue symptoms b −5.3 (−8.7, −1.8) 6.1 (0.3, 12.0) Restless or agitated b −2.6 (−6.8, 1.6) 9.3 (2.1, 16.4) Thinking about illness a 9.4 (4.9, 13.9) −7.5 (−14.5, −0.5) Worried about dying a 6.1 (1.9, 10.3) −14.4 (−22.5, −6.4) Worried about health a 7.9 (3.5, 12.4) −9.7 (−16.6, −2.8) Visual analog scale a 2.4 (−0.2, 5.1) −0.6 (−5.5, 4.3) a Higher score indicates better outcome. b Higher score indicates worse outcome.