Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
40
Countries
2
Sites
6
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
- 13 Mar 2025 → ongoing
- Decision date (initial)
- 2024-11-11
- 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 |
|---|---|---|---|---|
| 21.0 | 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
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 6 | 3 |
| Spain | Ongoing, recruitment ended | 6 | 3 |
| Rest of world
Australia, United States, Brazil
|
— | 28 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II, Abteilung fur Onkologie/Haematologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Tuebingen AöR
Abteilung fur Innere Medizin II, Haematologie, Onkologie Rheumatololgie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Heidelberg AöR
Innere Medizin V: Haematologie, Onkologie und Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
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 | 2025-05-28 | 2025-05-28 | 2025-09-22 | ||
| Spain | 2024-11-27 | 2024-11-27 | 2025-09-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-63844
- Halt date
- 2024-12-04
- Member states concerned
- Spain
- Publication date
- 2024-12-18
- Reason
- Medicinal Product related, Sponsor decision, Study management related
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-25 | Spain | Acceptable 2024-11-07
|
2024-11-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-26 | Spain | Acceptable 2025-01-17
|
2025-01-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-13 | Spain | Acceptable 2025-05-09
|
2025-05-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-25 | Spain | Acceptable 2025-08-28
|
2025-08-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-20 | Spain | Acceptable 2026-02-13
|
2026-02-16 |