Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
90
Countries
4
Sites
15
Relapsed or 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
- 21 Nov 2022 → ongoing
- Decision date (initial)
- 2023-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503679-12-00
- EudraCT number
- 2022-001465-12
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or 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
4 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 16 | 3 |
| France | Ongoing, recruiting | 23 | 4 |
| Netherlands | Ongoing, recruiting | 12 | 3 |
| Spain | Ongoing, recruiting | 24 | 5 |
| Rest of world
United Kingdom
|
— | 15 | — |
Investigational sites
CHU De Liege
Hematology, Avenue De L'hopital 1, 4000, Liege
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Antwerp University Hospital
Datacenter Hematologie, Drie Eikenstraat 655, 2650, Edegem
Centre Hospitalier Lyon Sud
Centre Hospitalier Lyon Sud Service d’Hématologie Clinique Pavillon 1F, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Universitaire Du Cancer Toulouse-Oncopole
Institut Universitaire du Cancer de Toulouse-Oncopole Unité de recherche clinique, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Rennes
Hôpital Pontchaillou Service d’Hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nantes
Service Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Amsterdam UMC
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Utrecht
Oncology/ Hematology, Heidelberglaan 100, 3584 CX, Utrecht
METC Universitair Medisch Centrum Groningen
Hematology, P. O. Box 30001, 9700 RB, Groningen
Clinica Universidad De Navarra
Ensayos clínicos de hematología, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Germans Trias I Pujol
NA, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Clinic De Barcelona
NA, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
ensayos clinicos de hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
NA, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 | 2022-11-21 | 2022-11-22 | |||
| France | 2023-01-10 | 2023-02-15 | |||
| Netherlands | 2023-04-18 | 2023-07-18 | |||
| Spain | 2023-02-13 | 2023-04-21 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-23 | Belgium | Acceptable 2023-08-08
|
2023-08-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-22 | Belgium | Acceptable 2024-02-27
|
2024-02-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-22 | Belgium | Acceptable 2024-07-01
|
2024-07-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-16 | Acceptable 2024-07-01
|
2024-08-16 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-16 | Belgium | Acceptable 2024-07-01
|
2024-08-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-25 | Belgium | Acceptable 2025-01-10
|
2025-01-10 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-24 | Belgium | Acceptable 2025-05-08
|
2025-05-08 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-19 | Belgium | Acceptable 2026-02-20
|
2026-02-23 |