Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
38
Countries
1
Sites
3
Patients diagnosed with multiple myeloma
Key facts
- Sponsor
- Centr Georges Francois Leclerc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 Dec 2020 → ongoing
- Decision date (initial)
- 2024-08-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516682-36-00
- EudraCT number
- 2019-003627-38
- ClinicalTrials.gov
- NCT04349358
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients diagnosed with multiple myeloma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centr Georges Francois Leclerc
- Sponsor organisation
- Centr Georges Francois Leclerc
- Address
- 1 Rue Professeur Marion
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Dr Clément DROUET
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Dr Clément DROUET
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 38 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Besancon
25, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centr Georges Francois Leclerc
21, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Dijon
21, 14 Rue Paul Gaffarel, 21000, Dijon
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 | 2020-12-15 | 2020-12-15 | 2023-02-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-24 | France | Acceptable 2024-08-20
|
2024-08-23 |