Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
80
Countries
3
Sites
9
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
- 22 Jun 2022 → ongoing
- Decision date (initial)
- 2024-05-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502681-24-00
- EudraCT number
- 2021-005073-22
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
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 34 | 4 |
| Germany | Ongoing, recruitment ended | 9 | 2 |
| Spain | Ongoing, recruitment ended | 17 | 3 |
| Rest of world
United States
|
— | 20 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
Service d'Oncologie Hématologique et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology Department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Montpellier
Département d'Hématologie Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nantes
Department of Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II; Abt. für Onkologie/Hämatologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Technische Universitaet Dresden
Medizinische Fakultät Carl Gustav Carus, Medizinische Klinik I, Hämatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
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 |
|---|---|---|---|---|---|
| France | 2022-06-22 | 2022-06-22 | 2024-07-02 | ||
| Germany | 2022-08-11 | 2022-08-11 | 2024-07-02 | ||
| Spain | 2022-08-24 | 2022-08-24 | 2024-07-02 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-26 | Spain | Acceptable 2024-04-26
|
2024-04-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-16 | Spain | Acceptable 2025-02-25
|
2025-02-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-18 | Spain | Acceptable 2026-03-30
|
2026-03-31 |