Desafios de condução de um teste controlado aleatório piloto de viabilidade durante as restrições COVID-19: Rivaroxabano versus ácido salicílico Acetil em pacientes com mieloma múltiplo em terapia baseada em lenalidomida (RithMM)

Resumo original em inglês

O que aconteceu

Venous thromboembolism is a serious medical complication with an increased risk in patients with multiple myeloma undergoing combination treatment regimens. Acetylsalicylic acid is routinely used as a method of thromboprophylaxis in multiple myeloma patients treated with lenalidomide, and rivaroxaban has been assessed in small-scale studies in multiple myeloma patients treated with immunomodulatory drugs; yet, no study has compared the two methods. In this pilot, we asked if a full-scale trial would be feasible to assess the benefits of rivaroxaban over acetylsalicylic acid as a thromboprophylactic approach. This pilot recruited patients with multiple myeloma on lenalidomide-based therapy and randomized them to either low-dose acetylsalicylic acid or rivaroxaban, then monitored bleeding and thrombotic events throughout lenalidomide-dexamethasone treatment. A total of 55 patients were recruited across three Canadian centres, with two venous thromboembolic events and two bleeding events, all in the acetylsalicylic acid arm. We conducted a post hoc analysis of active recruitment time as a definition of recruitment feasibility, as we did not achieve our pre-defined feasibility goals. Despite the challenges in enrollment, possibly due to social restrictions during the COVID-19 pandemic, we maintain that a full-scale trial is feasible and offers insight into thromboprophylactic management in this population.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.