Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
100
Countries
2
Sites
5
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
- 24 Feb 2025 → ongoing
- Decision date (initial)
- 2024-12-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10035226 | Plasma cell myeloma | 100000004864 |
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 |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 22 | 3 |
| Spain | Ongoing, recruiting | 10 | 2 |
| Rest of world
Israel, Australia
|
— | 68 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-02-24 | 2025-02-24 | |||
| Spain | 2025-02-25 | 2025-02-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Netherlands | Acceptable 2024-12-16
|
2024-12-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-19 | Netherlands | Acceptable 2025-03-28
|
2025-03-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-02 | Netherlands | Acceptable 2025-08-15
|
2025-08-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-26 | Netherlands | Acceptable 2026-03-20
|
2026-03-20 |