Clinical trial • Phase III • Oncology|Haematology
18F-Fludarabine for Multiple myeloma
Phase III trial of 18F-Fludarabine for Multiple myeloma. 35 participants.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 30-09-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
Phase III trial across 5 sites in France.
- Target Sample Size
- 35
- Trial Duration For Participant
- 2738
Recruitment
- Planned Sample Size
- 35
- Recruitment Window Months
- 90
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 35
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 298
- Number Of Sites
- 5
- Number Of Participants
- 35
Sites
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- hematology
- Contact Person Name
- Jonathan FARHI
- Contact Person Email
- jonathan.farhi@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- nuclear medecine
- Contact Person Name
- Caroline MILIN
- Contact Person Email
- caroline.milin@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- nuclear medecine
- Contact Person Name
- solène querellou
- Contact Person Email
- solene.querellou@chu-brest.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- nuclear medecine
- Contact Person Name
- maria Joao santiago-ribeiro
- Contact Person Email
- maria.ribeiro@univ-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- hematology
- Contact Person Name
- Baptiste DELAPIERRE
- Contact Person Email
- delapierre-ba@chu-caen.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nantes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- 18F-Fludarabine PET
- Active Substance
- 18F-Fludarabine
- Modality
- Radiopharmaceutical
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