OBJECTIVES: The management of multiple myeloma (MM) has changed considerably yet real-world data on treatment patterns are scarce. The PREMIERE study estimated Progression Free Survival (PFS), Overall Survival (OS) and toxicity in patients with a first episode of Relapse/Refractory Multiple Myeloma (RRMM) in Spain.

METHODS: Retrospective cohort chart review study of patients with RRMM over 3 years in 31 hematology centers. Patients ≥18 years with ≥1 prior lines of treatment (LOTs) for MM, starting a LOT for RRMM (index therapy, LOT1) were followed up. PFS and OS were described for LOT1 and subsequent LOTs (LOT2+), and by the most frequent treatment strategies (n >40) in LOT1 using Kaplan-Meier with estimation of the time to PFS and OS (median time-to-event in months, (Q1-Q3)).

RESULTS: Of 284 patients (median follow-up=20.1 months) 161 (56.7%) reached LOT2+. Progression occurred in 53.4% in LOT1, deaths in 24.7%. In LOT2+, deaths increasingly replaced progression: 49.7% progression in LOT2 to 21.43% in LOT5, vs 23.6% deaths in LOT2 to 64.3% in LOT5. Toxicity led to a change in LOT in approximately 10% in LOTs 1, 2 and 4. Longer PFS was observed in LOT1 vs LOT2+ (10.4 months, (8.7-12.6); 6.3 months, (4.4-8.2); p<0.05). OS was higher in LOT1 [Q1 and median not reached (NR), Q3=33.4 months vs 25.8 months (19.7-NR) in LOT2+; p=0.034]. Progression/mortality percentage by main treatment strategies in LOT1 was lower in patients with lenalidomide+dexamethasone at LOT1 (n=109) than in patients on bortezomib+dexamethasone (n=47), or chemotherapy (=41), but PFS and OS between LOT 1 and LOT2+ were not significantly different by LOT1 treatment strategies.

CONCLUSIONS: Real-world data from a large follow-up study of patients treated for a first episode of RRMM in Spain showed poorer PFS and OS in LOT2+ than in LOT1. This highlights the need for more effective therapies and treatment strategies.