European Post-Approval Safety Study (Registry) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety of Patients Treated with Pomalidomide
Authors: Di Raimondo Francesco , Kyriakou Charalampia , Schmidt-Hieber Martin , Vekemans Marie-Christiane , Ramírez Payer Ángel , Bentsen Pal Tore , Lauri Birgitta , Kueenburg Elisabeth , Lersch Frederik , Rosettani Barbara , Bacon Pamela , Plesner Torben 
Published: November 2019

Abstract
Background: This EU PASS is an observational, non-interventional registry designed to characterize the safety profile of pomalidomide (POM) in the treatment of RRMM in a real-world setting.
Objectives:To assess the incidence of adverse events (AEs) of special interest, including neutropenia, thrombocytopenia, venous thromboembolism, peripheral neuropathy, and second primary malignancies in patients (pts) with RRMM treated with POM according to current clinical practice.
Methods: Pts with symptomatic RRMM were enrolled at the investigator's discretion and after the decision was made to treat with POM. Thromboprophylaxis was administered per local standard practice. AEs were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4). The study is ongoing and open for recruitment in centers across Europe.
Results: As of June 2016, 218 pts across 100 institutions in 8 European countries were included in the safety population. At the time of this abstract, 153 pts (70.2%) were ongoing. Median age was 68 yrs (range, 37-88 yrs), with 39.9% of pts < 65 yrs, 32.6% between 65 and 75 yrs, and 27.5% ≥ 75 yrs; 56.9% were male. Median time from diagnosis was 4.7 yrs (range, 0.4-25.4 yrs). Median number of prior therapies was 3 (range, 0-10); 80.8% of pts had at least 3 prior lines. Most pts (95%) received prior lenalidomide (given in second line in 66.1% and in third line in 20.2%). Prior bortezomib was administered in 96.8% of pts (given in second line in 54.6% and in third line in 28.4%). Almost half of the pts (49.5%) had a good performance status (Eastern Cooperative Oncology Group performance status 0-1). In this analysis, median treatment duration was 12.9 wks (range, 0.7-87.9 wks).
Overall, 50.9% of pts (n = 111) had grade 3-4 AEs. AEs of all grades occurred in 79.8% (n = 174). Neutropenia of all grades was only reported in 22% of pts (n = 48), and febrile neutropenia in 2.3% of pts (n = 5). Infections of all grades occurred in 44.5% of pts (n = 97); of those, 11.5% were pneumonia. Thrombocytopenia occurred in 7.8% (n = 17). Fatigue occurred frequently in 13.8% of pts (n = 30). There were some gastrointestinal disorders, such as diarrhea in 7.8% (n = 17), constipation in 6.4% (n = 14), and nausea in 6.0% (n = 13) of pts. Peripheral polyneuropathy was uncommon (3.2%; n = 8). Acute myocardial infarction and deep vein thrombosis were observed in 1 pt each, and 1 pt developed basal cell carcinoma.
Conclusions: Results of this ongoing non-interventional study in RRMM on the use of POM in the real-world setting show a similar AE profile to that in the pivotal trial published by San Miguel in Lancet Oncology (2013). POM was generally well tolerated, and the overall safety profile is similar to that seen in pivotal trials. Updated data will be presented at the meeting.

Disclosures
Di Raimondo: ARIAD; Bristol-Myers Squibb; Novartis; Roche: Consultancy; Bristol-Myers Squibb; Celgene; Novartis: Speakers Bureau; Gilead Sciences: Other: Travel Expenses. Bentsen:Celgene, Teva: Other: Travel expenses. Kueenburg:Celgene International Sarl: Consultancy, Honoraria. Lersch:Celgene: Employment. Bacon:Celgene: Employment, Equity Ownership. Plesner:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding.