OBJECTIVES: Daratumumab is an anti-CD38 monoclonal antibody approved for relapsed/ refractory multiple myeloma (MM) treatment, as monotherapy or in combination with bortezomib or lenalidomide. This study aims to characterize treatment outcomes in real world context which are scarce.

METHODS: Retrospective observational descriptive study over a 33 month period (July 2016 to March 2019). Data was collected from electronic medical records.

RESULTS: Seventeen patients, ten female and seven male, with a median age of 71 years (57-81) were enrolled. The most common type of MM was IgG kappa (n=8, 47.0%), followed by IgG lambda (n =3, 17.7%). High cytogenetic risk was present in 4 patients (23.5%). In relation to International Staging System Score, 3 patients (21.4%) had an ISS I, seven (50.0%) ISS II and four ISS III (28.6%). Three patients had missing data.

The median previous treatment lines were 2 (0-8), including bortezomib (76.4%) and lenalidomide (88.2%).

Six patients (35.3%) were treated with Daratumumab in monotherapy, eight (47.0%) daratumumab + lenalidomide (DRd) and three (17.7%) daratumumab + bortezomib (DVd). In the DRd group all patients were previously exposed to bortezomib and 4 (50%) to bortezomib and lenalidomide. In the DVd group all were exposed to both medicines.

The ORR for the Daratumumab group was 16.7%, with median treatment duration of 0.9 months (0.7-2.1). For the DRd group it was 75%, 14.7 months (1.6-24.8) and for the DVd group was 100%, 6.6 months (4.2-21.2). The median time for first response was 1.5 months (0.37-6.53).

The most common adverse events of any grade were peripheral neuropathy (n=8, 53.3%), asthenia (n=6, 40.0%) and anaemia (n=5, 33.3%).

CONCLUSIONS: Our study seems to indicate that treatment with daratumumab in association with both lenalidomide and bortezomib has a promising effectiveness in a real-world context. The safety profile is comparable to the clinical trials already conducted.