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
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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