European Post-Approval Safety Study (EU Pass) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety, Including Second Primary Malignancies, in a Large Cohort of Patients (Pts) Treated With Lenalidomide (LEN), Thalidomide (THAL), and Bortezomib (BORT)

ResultsAs of March 1, 2016, 3630 pts were included in the safety population; 2151 (59.3%) received LEN, 1187 (32.7%) received BORT, 137 (3.8%) received THAL, and 155 (4.3%) received other therapies. The median duration on study Tx was 6.6 mos (range 0.1-79.9 mos) for pts receiving LEN, 4.1 mos (range 0-61.4 mos) for BORT, and 4.6 mos (range 0.2-36.9 mos) for THAL. At the time of analysis, 3557 pts (98.0%) had discontinued Tx and 73 pts (2.0%) were ongoing (63 LEN, 6 BORT, 0 THAL, and 4 others). Baseline characteristics were similar across cohorts. Median age was 70 yrs (range 25-95 yrs); 54.0% of pts were male. Of 2985 pts with available ECOG scores, 2865 (96.0%) had an ECOG score 0-2. The median number of prior therapies was 1 (range 1-6); the proportion of pts with only 1 prior Tx was lower in the LEN (44.2%) vs BORT (70.8%) and THAL (56.2%) cohorts. Overall, 1843 pts (50.8%) had …