Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
50
Countries
1
Sites
13
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
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 5 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509383-15-00
- EudraCT number
- 2018-001960-45
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
- Philippe MOREAU
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Philippe MOREAU
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 50 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
hematology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Lille
hematology, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
hematology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Rennes
hematology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire Grenoble Alpes
hematology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Hospices Civils De Lyon
hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Universitaire Du Cancer Toulouse-Oncopole
hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Caen Normandie
hematology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Departemental Vendee
hematology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Regional Universitaire De Tours
hematology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Dijon
hematology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Nantes
hematology, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
CHRU De Nancy
hematology, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
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 | 2024-07-05 | 2024-07-05 | 2024-07-05 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-05 | France | Acceptable 2024-07-02
|
2024-07-05 |