Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
20
Countries
1
Sites
1
multiple myeloma
Key facts
- Sponsor
- Oslo University Hospital Hf
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 19 May 2023 → ongoing
- Decision date (initial)
- 2022-12-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
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 |
| 20.0 | LLT | 10075894 | Smoldering myeloma | 10029104 |
| 20.0 | LLT | 10028232 | Multiple myeloma myelomatosis | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital Hf
- Sponsor organisation
- Oslo University Hospital Hf
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital Hf
- Contact name
- Fredrik Schjesvold
Public contact point
- Organisation
- Oslo University Hospital Hf
- Contact name
- Fredrik Schjesvold
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Norway | 2023-05-19 | 2023-05-31 | 2026-03-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-20 | Norway | Acceptable 2022-12-21
|
2022-12-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-05 | Norway | Acceptable 2023-11-30
|
2023-11-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-16 | Norway | Acceptable 2023-11-30
|
2024-02-16 |