Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
35
Countries
1
Sites
5
multiple myeloma
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 8 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515219-23-00
- EudraCT number
- 2018-002723-42
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
multiple myeloma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Caroline BODET-MILIN
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Caroline BODET-MILIN
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 35 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Caen Normandie
hematology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Regional D'Angers
hematology, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional Universitaire De Tours
nuclear medecine, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Regional Et Universitaire De Brest
nuclear medecine, 2 Avenue Marechal Foch, 29200, Brest
Centre Hospitalier Universitaire De Nantes
nuclear medecine, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-11-08 | 2024-11-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | France | Acceptable 2024-11-08
|
2024-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-30 | France | Acceptable | 2025-08-08 |