Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
220
Countries
1
Sites
2
Relapsed or refractory multiple myeloma
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Nov 2023 → ongoing
- Decision date (initial)
- 2023-11-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506993-11-00
- EudraCT number
- 2020-000199-40
- ClinicalTrials.gov
- NCT03933735
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or refractory multiple myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10035226 | Plasma cell myeloma | 100000004864 |
| 22.0 | PT | 10081847 | Plasma cell myeloma refractory | 100000004864 |
| 21.1 | LLT | 10067095 | Multiple myeloma progression | 10029104 |
| 20.0 | LLT | 10028566 | Myeloma | 10029104 |
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruiting | 22 | 2 |
| Rest of world
United States
|
— | 198 | — |
Investigational sites
University Medical Center Hamburg-Eppendorf
Onkologie, Hämatologie, KMT mit Abteilung für Pneumologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
UCC/NCT Early Clinical Trial Unit, 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 |
|---|---|---|---|---|---|
| Germany | 2023-11-23 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-03 | Germany | Acceptable 2023-11-16
|
2023-11-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Germany | Acceptable 2024-04-05
|
2024-04-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-22 | Germany | Acceptable 2024-10-15
|
2024-10-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-07 | Germany | Acceptable 2025-08-29
|
2025-08-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-04 | Germany | Acceptable 2025-12-04
|
2025-12-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-06 | Germany | Acceptable 2025-12-04
|
2026-03-06 |