Observational Italian Study on Siltuximab for Adults with Relapsed or Refractory Castleman Disease in Real-Life Treatment

What this Trial Is About

Researchers are conducting a retrospective observational study to collect and evaluate data from patients with relapsed or refractory Multicentric Castleman Disease MCD who were treated with siltuximab in real-life clinical settings across 31 Italian centers between July 2016 and April 2022. The study aims to provide more information on the use, effectiveness, and safety of siltuximab in this rare condition, based on data routinely collected during normal clinical practice without any additional interventions. This study involves reviewing medical records of patients who received at least one dose of siltuximab as part of their standard treatment. No new treatments or procedures will be administered as part of the study. Researchers will examine clinical variables and outcomes related to siltuximab treatment, focusing on how patients responded and tolerated the medication in everyday care. Participants involvement consists of the collection of their existing medical data only, without any extra visits or procedures outside routine care. The main outcome measured is the overall response rate after siltuximab treatment. Secondary outcomes include duration of response, progression-free survival, overall survival, duration free survival, best response rate, and safety and tolerability of siltuximab. The study is observational and non-interventional, ensuring participants are monitored through their usual clinical records without additional study-related interventions.

An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context