Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
80
Countries
1
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] - Neoplasms [C04]
- Trial duration
- 30 Apr 2025 → 22 May 2026
- Decision date (initial)
- 2024-10-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
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
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 15 | 5 |
| Rest of world
Australia, Taiwan, Canada, Korea, Democratic People's Republic of
|
— | 65 | — |
Investigational sites
Clinica Universidad De Navarra
Ensayos Clínicos de Hematología, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario De Salamanca
Ensayos Clinicos de Hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
Unidad de Ensayos Fase I, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Institut Catala D'oncologia
Hemarología, Carretera Canyet S/n, 08916, Badalona
Hospital Clinic De Barcelona
Hematología, Calle Villarroel 170, 08036, Barcelona
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 |
|---|---|---|---|---|---|
| Spain | 2025-04-30 | 2026-05-22 | 2025-04-30 | 2026-05-04 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-19 | Spain | Acceptable 2024-10-11
|
2024-10-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-19 | Spain | Acceptable 2025-02-24
|
2025-02-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-20 | Spain | Acceptable 2025-12-09
|
2025-12-11 |