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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Castleman Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- overall response rate (ORR) [Time frame: after the end of siltuximab infusion]
Secondary outcome measures (6)
- Duration of response (DoR) [Time frame: before, during and after the end of siltuximab infusion]
- Progression-free survival (PFS) [Time frame: before, during and after the end of siltuximab infusion]
- Overall Survival (OS) [Time frame: before, during and after the end of siltuximab infusion]
- Duration Free Survival (DFS) [Time frame: before, during and after the end of siltuximab infusion]
- Best response rate (BRR) [Time frame: before, during and after the end of siltuximab infusion]
- safety and tolerability of siltuximab [Time frame: before, during and after the end of siltuximab infusion]
Eligibility criteria
Inclusion criteria
- Histologically confirmed diagnosis of R/R MCD HIV and HHV-8 negative patients who underwent siltuximab in a real-life context from July 2016 till April 2022.
- Age ≥ 18 yearsatenrollment
- Signature of written informed consent (where applicable)
Exclusion criteria
1\. R/R MCD patients who underwent siltuximab in a clinical trial context
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 12 centers
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
- Azienda Ospedaliera Sant'Anna e San Sebastiano — Caserta
- Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari
- Azienda Ospedaliera Universitaria Arcispedale Sant'Anna — Ferrara
- Azienda Ospedaliero Universitaria Careggi — Florence
- Irccs Ospedale San Raffaele — Milan
- Azienda Ospedaliero-Universitaria "Maggiore della Carità" — Novara
- Azienda Ospedaliera Di Padova — Padova
- … and 4 more centers
Identifiers
NCT: NCT06720870 · SilOs