Clinical trial • Phase I/II | Phase III • Haematology
Teclistamab for Relapsed/Refractory multiple myeloma
Phase I/II | Phase III trial of Teclistamab for Relapsed/Refractory multiple myeloma. 97 participants.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Relapsed/Refractory multiple myeloma
- Trial Stage
- Phase I/II | Phase III
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 05-04-2024
- First CTIS Authorization Date
- 21-06-2024
Trial design
Phase I/II | Phase III trial across 5 sites in Belgium, France.
- Target Sample Size
- 97
Recruitment
- Planned Sample Size
- 97
- Recruitment Window Months
- 75
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 43
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 25-06-2024
- Processing Time Days
- 97
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Fritz Offner
- Principal Investigator Email
- fritz.offner@uzgent.be
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@uzgent.be
- Site Name
- Antwerp University Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Sébastien Anguille
- Principal Investigator Email
- sebastien.anguille@uza.be
- Contact Person Name
- Sébastien Anguille
- Contact Person Email
- sebastien.anguille@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 21-06-2024
- Processing Time Days
- 93
- Number Of Sites
- 3
- Number Of Participants
- 28
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service d'Hématologie Clinique
- 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
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service d’Hématologie
- 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 Leon Berard
- Department Name
- Service Oncologie médicale / Hématologie
- Principal Investigator Name
- Anne-Sophie MICHALLET
- Principal Investigator Email
- Anne-Sophie.MICHALLET@lyon.unicancer.fr
- Contact Person Name
- Anne-Sophie MICHALLET
- Contact Person Email
- Anne-Sophie.MICHALLET@lyon.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Teclistamab
- Active Substance
- Teclistamab
- Modality
- Bispecific antibody
- Combination Treatment
- Yes
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