Background and importance Multiple myeloma (MM) is an incurable disease that is associated with severe symptoms affecting health related quality of life (HRQoL). Here we report the impact of treatment on disease burden in terms of HRQoL and direct health costs.

Aim and objectives Primary endpoints were HRQoL (baseline and at 5 months), reported by EuroQol-5D (EQ-5D) and QLQ (quality of life questionnaire)-C30/QLQ-MY20 questionnaires and direct health costs.

Material and methods QoLMMBuS (NCT 02946333) is an ongoing, prospective, observational study conducted in 53 Spanish sites in patients with MM not eligible for autologous stem cell transplantation (ASCT). The interim cut-off date was November 2018.

Results A total of 161 evaluable patients were enrolled between November 2016 and October 2018. Median age (range) was 77.6 (73.9–82.6) years, 44.7% were men, and 57.8% of patients had Eastern Cooperative Oncology Group (ECOG) stage 0/I, 41.6% stage II (R-ISS), 66.2% disease isotype IgG and 33.1% disease isotype IgA. High risk cytogenetics were detected in 18% of patients. In total, 156 patients received lenalidomide (32.0%) or bortezomib (68.0%) as firstline therapy. With a median follow-up of 5.0 months (3.5–11.1), response rates were: complete response in 17.9%, very good partial response in 28.4%, partial response in 38.8% and progression of disease in 1.5%: 61.5% of patients remained on firstline therapy. EQ-5D and QLQ C30 (at 5 months) showed an increase in HRQoL mean values for the key domains of global health status/QoL, physical, role and emotional functioning, although patients experienced worsening in dyspnoea (p=0.003). The mean QLQ-MY20 values showed a significant improvement for the domains of disease symptoms (p=0.037) and future perspective (p=0.010) and worsening for side effects and body image. A total of 56.4% patients experienced at least one adverse event and 77.8% and 79.9% of patients went to visit their doctor or outpatients, respectively. Hospital admissions reported were 154 with a mean (SD) time of 18.3 days for hospitalised patients. Mean direct cost of hospitalisation/patient was 6670.9 €. Annual mean cost was 13 748€ per patient and 48.5% of the cost was related to hospitalisation.

Conclusion and relevance Lenalidomide and bortezomib were the main drugs used as firstline treatment of MM patients not eligible for ASCT. These preliminary analyses indicate that patients experienced a significant improvement in disease symptoms and future perspective and a significant worsening in dyspnoea within the first months, with lower impact on direct health costs over time. The efficacy and safety profile remained favourable at the time of analysis.

Conflict of interest Corporate sponsored research or other substantive relationships:

JdlR: grants, Celgene Corporation; consultancy, AMGEN, Celgene Corporation, Janssen and Takeda. AD: personal fees, Celgene Corporation. ODS: advisory boards, Celgene; grants, Celgene; study financial support, Hospital Universitari Son Espases. AL: grants to attend medical meetings, Celgene Corporation. GL: personal fees, Celgene Corporation. MVM: personal fees, Celgene Corporation, Janssen, Takeda, Amgen, GSK, Abbvie, Pharmamar, EDIO, Adaptive and Sanofi.