Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
140
Countries
2
Sites
5
Relapsed/Refractory 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] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 8 Mar 2021 → ongoing
- Decision date (initial)
- 2024-06-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503440-14-00
- EudraCT number
- 2020-004404-33
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory 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
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 15 | 2 |
| France | Ongoing, recruitment ended | 28 | 3 |
| Rest of world
Australia, United Kingdom, United States
|
— | 97 | — |
Investigational sites
Antwerp University Hospital
Hematology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Universitaire De Bordeaux
Service d’Hématologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nantes
Service d'Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Leon Berard
Service Oncologie médicale / Hématologie, 28 Rue Laennec, 69008, Lyon
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 | 2021-03-08 | 2021-03-08 | 2022-02-08 | ||
| France | 2021-03-09 | 2021-03-09 | 2022-04-04 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-05 | France | Acceptable 2024-06-21
|
2024-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-10 | France | Acceptable 2025-02-21
|
2025-02-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-13 | Acceptable 2025-02-21
|
2025-03-13 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-14 | France | Acceptable 2025-02-21
|
2025-03-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-14 | France | Acceptable 2025-04-22
|
2025-04-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-20 | France | Acceptable 2026-02-04
|
2026-02-04 |