Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
166
Countries
3
Sites
9
multiple myeloma
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Dec 2021 → ongoing
- Decision date (initial)
- 2024-05-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503620-60-00
- EudraCT number
- 2020-004502-55
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
multiple myeloma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 10 | 2 |
| France | Ongoing, recruitment ended | 27 | 4 |
| Netherlands | Ongoing, recruitment ended | 12 | 3 |
| Rest of world
United Kingdom, United States, Australia
|
— | 117 | — |
Investigational sites
Antwerp University Hospital
Hematology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Department of Hematology, Corneel Heymanslaan 10, 9000, Gent
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Nantes
Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Rennes
Hematology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Bordeaux
Hematology, Avenue De Magellan, 33600, Pessac
Universitair Medisch Centrum Utrecht
afdeling Hematologie, Heidelberglaan 100, 3584 CX, Utrecht
Universitair Medisch Centrum Groningen
Department of Hematology, Hanzeplein 1, 9713 GZ, Groningen
University Hospital Maastricht
Department of Internal Medicine/ Hematology, P Debyelaan 25, 6229 HX, Maastricht
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 |
|---|---|---|---|---|---|
| Belgium | 2022-01-14 | 2025-01-27 | 2022-01-25 | 2024-07-18 | |
| France | 2021-12-22 | 2022-01-21 | 2024-07-18 | ||
| Netherlands | 2022-02-25 | 2022-03-07 | 2024-07-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-05 | Netherlands | Acceptable 2024-05-08
|
2024-05-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-17 | Netherlands | Acceptable 2025-03-24
|
2025-03-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-22 | Netherlands | Acceptable 2025-12-04
|
2025-12-05 |