Clinical trial • Phase III • Oncology
Cevostamab for Multiple myeloma | Relapsed or refractory multiple myeloma
Phase III trial of Cevostamab for Multiple myeloma | Relapsed or refractory multiple myeloma. 88 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma | Relapsed or refractory multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 15-07-2024
- First CTIS Authorization Date
- 27-08-2024
Trial design
Phase III trial across 13 sites in Denmark, France, Poland and others.
- Target Sample Size
- 88
Recruitment
- Planned Sample Size
- 88
- Recruitment Window Months
- 38
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 50
Denmark
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 28-08-2024
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Rigshospitalet
- Department Name
- Hæmatologisk klinik
- Principal Investigator Name
- Anna Caroline Riley
- Principal Investigator Email
- anna.caroline.riley@regionh.dk
- Contact Person Name
- Anna Caroline Riley
- Contact Person Email
- anna.caroline.riley@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 29-08-2024
- Processing Time Days
- 31
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service Oncologie Hématologique et Thérapie Cellulaire / Centre d’investigation clinique
- 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
- Hospital Hotel Dieu
- Department Name
- Service d’Hématologie
- 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
- Hopital Saint Louis
- Department Name
- Service Immuno-Hématologie / Centre d’investigation clinique
- Principal Investigator Name
- Bertrand Arnulf
- Principal Investigator Email
- bertrand.arnulf@aphp.fr
- Contact Person Name
- Bertrand Arnulf
- Contact Person Email
- bertrand.arnulf@aphp.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 22-09-2024
- Processing Time Days
- 55
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Pratia Onkologia Katowice
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- kontakt.onkologia.katowice@pratia.com
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- kontakt.onkologia.katowice@pratia.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Dominik Dytfeld
- Principal Investigator Email
- sekretariat.hematologia@usk.poznan.pl
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- sekretariat.hematologia@usk.poznan.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Monika Szarejko
- Principal Investigator Email
- klhem@gumed.edu.pl
- Contact Person Name
- Monika Szarejko
- Contact Person Email
- klhem@gumed.edu.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Principal Investigator Name
- Jana Mihalyova
- Principal Investigator Email
- jana.mihalyova@fno.cz
- Contact Person Name
- Jana Mihalyova
- Contact Person Email
- jana.mihalyova@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. Interni klinika
- Principal Investigator Name
- Ivan Spicka
- Principal Investigator Email
- spicka@cesnet.cz
- Contact Person Name
- Ivan Spicka
- Contact Person Email
- spicka@cesnet.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Mercedes Gironella
- Principal Investigator Email
- mgironella@vhio.net
- Contact Person Name
- Mercedes Gironella
- Contact Person Email
- mgironella@vhio.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hematology
- Principal Investigator Name
- Cristina Encinas
- Principal Investigator Email
- cristina.encinas@salud.madrid.org
- Contact Person Name
- Cristina Encinas
- Contact Person Email
- cristina.encinas@salud.madrid.org
Italy
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 10-09-2024
- Processing Time Days
- 43
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. di Ematologia
- Principal Investigator Name
- Angelo Belotti
- Principal Investigator Email
- angelo.belotti@asst-spedalicivili.it
- Contact Person Name
- Angelo Belotti
- Contact Person Email
- angelo.belotti@asst-spedalicivili.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Monica Galli
- Principal Investigator Email
- monicagalli@asst-pg23.it
- Contact Person Name
- Monica Galli
- Contact Person Email
- monicagalli@asst-pg23.it
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Cevostamab
- Active Substance
- Cevostamab
- Modality
- Bispecific antibody
- Investigational Product Name
- Pomalidomide
- Active Substance
- Pomalidomide
- Modality
- Small molecule
- Investigational Product Name
- Dexamethasone
- Active Substance
- Dexamethasone
- Modality
- Small molecule
- Investigational Product Name
- Daratumumab
- Active Substance
- Daratumumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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