Objective:

To evaluate the effectiveness and safety of two different treatment sequences used in patients diagnosed with multiple myeloma who are not candidates for bone marrow transplantation according to usual clinical practice.

Material and methods:

Retrospective/ prospective follow-up non-interventional post-authorization observational study, conducted at a third level hospital from January 2015 to October 2019. The study was conducted in two phases: A retrospective phase where patients who had received bortezomib as retreatment in first relapse and lenalidomide in the second relapse, after having received a first-line with bortezomib, were analyzed; and a prospective phase where patients who were going to receive lenalidomide in the first relapse, followed by bortezomib in second relapse, were analyzed. The primary variable of the study was the time to progression (TTP) of each treatment sequence, and the secondary variables were global survival (SG), more frequent adverse reactions and others defined in the statistical analysis.

Results:

110 patients were included, 55 in the retrospective phase and 55 in the prospective phase. The median time free of progression per series was 29.0 months for patients in the retrospective series and 31.0 months for patients in the prospective series. The median overall survival was 61.0 months for patients in the retrospective series and 64.0 months for those in the prospective series.

Conclusions:

In terms of health outcomes, treatment sequence 2 using lenalidomide at first relapse was more effective and safe than treatment sequence 1 using bortezomib as retreatment.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )