Clinical trial • Phase I • Oncology
SAR446523 for Relapsed/refractory multiple myeloma
Phase I trial of SAR446523 for Relapsed/refractory multiple myeloma. 75 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed/refractory multiple myeloma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 21-08-2024
- First CTIS Authorization Date
- 09-12-2024
Trial design
Phase I trial across 6 sites in Italy, Spain, France.
- Target Sample Size
- 75
- Trial Duration For Participant
- 1550
Eligibility
Recruits 75 Vulnerable population selected (isVulnerablePopulationSelected: true); no details on consent or assent handling provided in source.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no details on consent or assent handling provided in source
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 50
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 28
Italy
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 10-12-2024
- Processing Time Days
- 22
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O di Oncologia Medica ed Ematologia
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Ematologica
- Contact Person Name
- Massimo Offidani
- Contact Person Email
- massimo.offidani@ospedaliriuniti.marche.it
Spain
- Earliest CTIS Part Ii Submission Date
- 31-07-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 131
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Unidad START-Madrid FJD
- Contact Person Name
- Daniel Morillo Giles
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Department of hematology
- Contact Person Name
- Mercedes Gironella Mesa
- Contact Person Email
- mgironel@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 24-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service d'hématologie clinique
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service des Maladies du Sang
- Contact Person Name
- Salomon Manier
- Contact Person Email
- salomon.manier@chru-lille.fr
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- SAR446523
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
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