Clinical trial • Phase III • Oncology
Clinical trial in Multiple myeloma
Phase III trial for Multiple myeloma. 117 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 05-04-2024
- First CTIS Authorization Date
- 08-05-2024
Trial design
Phase III trial across 9 sites in Belgium, France, Netherlands.
- Target Sample Size
- 117
Eligibility
Recruits 117 Vulnerable population selected; no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 117
- Recruitment Window Months
- 66
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 49
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-04-2024
- Latest Decision Or Authorization Date
- 27-03-2025
- Processing Time Days
- 342
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Department of Hematology
- Principal Investigator Name
- Nicolas Kint
- Principal Investigator Email
- Nicolas.Kint@uzgent.be
- Contact Person Name
- Nicolas Kint
- Contact Person Email
- Nicolas.Kint@uzgent.be
- Site Name
- Antwerp University Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Sébastien Anguille
- Principal Investigator Email
- studies.hematologie@uza.be
- Contact Person Name
- Sébastien Anguille
- Contact Person Email
- studies.hematologie@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 19-04-2024
- Latest Decision Or Authorization Date
- 25-03-2025
- Processing Time Days
- 340
- Number Of Sites
- 4
- Number Of Participants
- 27
Sites
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hematology
- Principal Investigator Name
- Olivier Decaux
- Principal Investigator Email
- olivier.decaux@chu-rennes.fr
- Contact Person Name
- Olivier Decaux
- Contact Person Email
- olivier.decaux@chu-rennes.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Hematology
- Principal Investigator Name
- Aurore Perrot
- Principal Investigator Email
- Perrot.Aurore@iuct-oncopole.fr
- Contact Person Name
- Aurore Perrot
- Contact Person Email
- Perrot.Aurore@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hematology
- Principal Investigator Name
- Cyrille Hulin
- Principal Investigator Email
- cyrille.hulin@chu-bordeaux.fr
- Contact Person Name
- Cyrille Hulin
- Contact Person Email
- cyrille.hulin@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hematology
- Principal Investigator Name
- Cyrille Touzeau
- Principal Investigator Email
- bp-secretariat-hemato-univ@chu-nantes.fr
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- bp-secretariat-hemato-univ@chu-nantes.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 19-04-2024
- Latest Decision Or Authorization Date
- 09-04-2025
- Processing Time Days
- 355
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- afdeling Hematologie
- Principal Investigator Name
- Monique Minnema
- Principal Investigator Email
- hemat-research@umcutrecht.nl
- Contact Person Name
- Monique Minnema
- Contact Person Email
- hemat-research@umcutrecht.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Department of Hematology
- Principal Investigator Name
- Wouter Johannes Plattel
- Principal Investigator Email
- trialbureauhematologie@onco.umcg.nl
- Contact Person Name
- Wouter Johannes Plattel
- Contact Person Email
- trialbureauhematologie@onco.umcg.nl
- Site Name
- University Hospital Maastricht
- Department Name
- Department of Internal Medicine/ Hematology
- Principal Investigator Name
- Catharina H.M.J. Van Elssen
- Principal Investigator Email
- research.hematologie@mumc.nl
- Contact Person Name
- Catharina H.M.J. Van Elssen
- Contact Person Email
- research.hematologie@mumc.nl
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
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