The study is a pilot, observational, retrospective, and (italian) multicenter study. The study will involve the collection of patient data from medical records for patients with Multicentric Castelman Disease Relapsed/Refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from July 2016 till April 2022 in 31selected italian centres.
The aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (R/R) MCD in a real-life context since approval as more data are needed to improve knowledge in this rare disease. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. Infact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.
Study Type
OBSERVATIONAL
Enrollment
65
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, Italy
RECRUITINGAzienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, Caserta, Italy
RECRUITINGPoliclinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
RECRUITINGAzienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, Italy
RECRUITINGAzienda Ospedaliero Universitaria Careggi
Florence, Italy
RECRUITINGIrccs Ospedale San Raffaele
Milan, Italy
RECRUITINGAzienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, Italy
RECRUITINGAzienda Ospedaliera Di Padova
Padua, Italy
RECRUITINGFondazione IRCCS Policlinico San Matteo
Pavia, Italy
RECRUITINGAzienda Ospedaliera Universitaria Senese
Siena, Italy
RECRUITING...and 2 more locations
overall response rate (ORR)
Primarily this study aims to evaluate retrospectively effectiveness in terms of ORR of siltuximab as a single agent in patients with R/R MCD treated with at least one dose of siltuximab in a real-life context
Time frame: after the end of siltuximab infusion
Duration of response (DoR)
Duration of response (DoR)
Time frame: before, during and after the end of siltuximab infusion
Progression-free survival (PFS)
Progression-free survival (PFS)
Time frame: before, during and after the end of siltuximab infusion
Overall Survival (OS)
Overall Survival (OS)
Time frame: before, during and after the end of siltuximab infusion
Duration Free Survival (DFS)
Duration Free Survival (DFS)
Time frame: before, during and after the end of siltuximab infusion
Best response rate (BRR)
Best response rate (BRR)
Time frame: before, during and after the end of siltuximab infusion
safety and tolerability of siltuximab
safety and tolerability of siltuximab
Time frame: before, during and after the end of siltuximab infusion
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