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

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
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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