Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
108
Countries
3
Sites
6
Plasma cell myeloma refractory
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Jul 2025 → ongoing
- Decision date (initial)
- 2025-09-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511667-28-00
- WHO UTN
- U1111-1301-4016
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Plasma cell myeloma refractory
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | PT | 10081847 | Plasma cell myeloma refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 11 | 2 |
| Italy | Ongoing, recruiting | 8 | 2 |
| Spain | Ongoing, recruiting | 10 | 2 |
| Rest of world
Australia, United States, Japan, Israel, Canada, China
|
— | 79 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Service des Maladies du Sang, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Nantes
Service d'hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
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 | 2025-11-17 | 2025-11-17 | |||
| Italy | 2025-07-21 | 2025-07-21 | |||
| Spain | 2025-12-02 | 2025-12-02 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Spain | Acceptable 2024-12-09
|
2024-12-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-31 | Spain | Acceptable 2025-03-11
|
2025-03-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-12 | Spain | Acceptable 2025-03-11
|
2025-05-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-14 | Acceptable | 2025-06-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-14 | Spain | Acceptable | 2025-06-12 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-06-25 | Acceptable 2025-03-11
|
2025-09-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-31 | Spain | Acceptable | 2025-09-09 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-24 | Acceptable | 2025-09-24 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-27 | Spain | Acceptable 2026-05-30
|
2026-06-01 |