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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | after the end of siltuximab infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | Duration of response (DoR) | before, during and after the end of siltuximab infusion |
| Progression-free survival (PFS) | Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
1. R/R MCD patients who underwent siltuximab in a clinical trial context
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Patients with R/R MCD who receive at least one dose of siltuximab in a real-life context from July 2016 till April 2022.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pier Luigi Zinzani, MD | Contact | +390512144042 | pierluigi.zinzani@unibo.it | |
| Beatrice Casadei, MD | Contact | +39 0512143680 | beatrice.casadei@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Pier Luigi Zinzani, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero - Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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| before, during and after the end of siltuximab infusion |
| Overall Survival (OS) | Overall Survival (OS) | before, during and after the end of siltuximab infusion |
| Duration Free Survival (DFS) | Duration Free Survival (DFS) | before, during and after the end of siltuximab infusion |
| Best response rate (BRR) | Best response rate (BRR) | before, during and after the end of siltuximab infusion |
| safety and tolerability of siltuximab | safety and tolerability of siltuximab | before, during and after the end of siltuximab infusion |
| Azienda Ospedaliera Sant'Anna e San Sebastiano | Recruiting | Caserta | Caserta | 81100 | Italy |
|
| Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico | Recruiting | Bari | 70124 | Italy |
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| Azienda Ospedaliera Universitaria Arcispedale Sant'Anna | Recruiting | Ferrara | 44124 | Italy |
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| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
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| Irccs Ospedale San Raffaele | Recruiting | Milan | 20100 | Italy |
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| Azienda Ospedaliero-Universitaria "Maggiore della Carità" | Recruiting | Novara | 28100 | Italy |
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| Azienda Ospedaliera Di Padova | Recruiting | Padova | 35128 | Italy |
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| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
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| Azienda Ospedaliera Universitaria Senese | Recruiting | Siena | 53100 | Italy |
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| Azienda ULSS 2 Marca Trevigiana - UOC Medicina Interna 1 Centro di Riferimento per le Malattie Rare del Sistema Immunitario e dell'Apparato Respiratorio | Recruiting | Treviso | 31100 | Italy |
|
| Azienda Ulss 2 Marca Trevigiana- Ospedale Di Treviso | Recruiting | Treviso | 31100 | Italy |
|
| ID | Term |
|---|---|
| D005871 | Castleman Disease |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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