Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
1
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
- 26 May 2021 → 6 May 2025
- Decision date (initial)
- 2024-08-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512640-36-00
- EudraCT number
- 2020-001983-26
- ClinicalTrials.gov
- NCT04570631
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
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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 1 | 1 |
| Rest of world
United States
|
— | 5 | — |
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 |
|---|---|---|---|---|---|
| Italy | 2021-05-26 | 2025-05-05 | 2021-09-03 | 2023-06-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-25 | Italy | Acceptable 2024-07-31
|
2024-08-05 |