Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
290
Countries
3
Sites
11
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
- 2 Mar 2020 → ongoing
- Decision date (initial)
- 2024-06-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503468-17-00
- EudraCT number
- 2019-000330-19
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 · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 29 | 4 |
| Netherlands | Ongoing, recruitment ended | 12 | 1 |
| Spain | Ongoing, recruitment ended | 70 | 6 |
| Rest of world
Canada, United States
|
— | 179 | — |
Investigational sites
Medical Center - University Of Freiburg
Klinik für Innere Medizin I, Hämatologie/Onkologie,, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Heidelberg AöR
Innere Medizin V Hämatologie/Onkologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II; Abt. für Onkologie/Hämatologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Medical Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Germans Trias I Pujol
Medical Oncology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario De Salamanca
Medical Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
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 |
|---|---|---|---|---|---|
| Germany | 2021-04-01 | 2021-04-07 | 2022-07-13 | ||
| Netherlands | 2020-03-31 | 2021-06-01 | 2022-06-27 | ||
| Spain | 2020-03-02 | 2020-03-03 | 2022-09-28 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-25 | Netherlands | Acceptable 2024-06-07
|
2024-06-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-21 | Netherlands | No conclusion 2025-03-24
|
2025-03-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-14 | No conclusion 2025-03-24
|
2025-11-14 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-14 | No conclusion 2025-03-24
|
2025-11-14 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-17 | Netherlands | No conclusion 2025-03-24
|
2025-11-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-24 | Netherlands | Acceptable 2026-02-04
|
2026-02-06 |