Clinical trial • Phase I/II • Oncology
Clinical trial in Relapsed or refractory multiple myeloma
Phase I/II trial for Relapsed or refractory multiple myeloma. 60 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory multiple myeloma
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-03-2024
- First CTIS Authorization Date
- 26-04-2024
Trial design
Phase I/II trial across 9 sites in Spain, France, Germany.
- Target Sample Size
- 60
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 57
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 28-02-2024
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 769
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Medical Oncology
- Principal Investigator Name
- Albert Oriol
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Principal Investigator Name
- Paula Rodriguez
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Medical Oncology
- Principal Investigator Name
- María Victoria Mateos
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- María Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
France
- Earliest CTIS Part Ii Submission Date
- 28-02-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 762
- Number Of Sites
- 4
- Number Of Participants
- 34
Sites
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Hematology Department
- 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 Montpellier
- Department Name
- Département d'Hématologie Clinique
- Principal Investigator Name
- Laure Vincent
- Principal Investigator Email
- l-vincent@chu-montpellier.fr
- Contact Person Name
- Laure Vincent
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d'Oncologie Hématologique et Thérapie Cellulaire
- Principal Investigator Name
- Xavier Leleu
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier Leleu
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Department of Hematology
- Principal Investigator Name
- Cyrille Touzeau
- Principal Investigator Email
- cyrille.touzeau@chu-nantes.fr
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 28-02-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 765
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Fakultät Carl Gustav Carus, Medizinische Klinik I, Hämatologie
- Principal Investigator Name
- Raphael Teipel
- Principal Investigator Email
- raphael.teipel@uniklinikum-dresden.de
- Contact Person Name
- Raphael Teipel
- Contact Person Email
- raphael.teipel@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II; Abt. für Onkologie/Hämatologie
- Principal Investigator Name
- Hermann Einsele
- Principal Investigator Email
- einsele_h@ukw.de
- Contact Person Name
- Hermann Einsele
- Contact Person Email
- einsele_h@ukw.de
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Combination Treatment
- Yes
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