Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
98
Countries
3
Sites
11
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
- 31 Jul 2023 → ongoing
- Decision date (initial)
- 2023-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504674-38-00
- ClinicalTrials.gov
- NCT05650632
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 |
|---|---|---|---|---|
| 21.0 | 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
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 15 | 2 |
| France | Ongoing, recruitment ended | 15 | 7 |
| Spain | Ongoing, recruitment ended | 15 | 2 |
| Rest of world
United States, Canada, United Kingdom, Israel
|
— | 53 | — |
Investigational sites
Odense University Hospital
N/A, J B Winsloews Vej 4, 5000, Odense C
Lillebaelt Hospital
N/A, Beriderbakken 4, 7100, Vejle
Centre Hospitalier Universitaire De Poitiers
N/A, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
N/A, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Assistance Publique Hopitaux De Paris
N/A, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Institut Universitaire Du Cancer Toulouse-Oncopole
N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nantes
N/A, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Lyon Sud
N/A, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Paoli-Calmettes
N/A, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
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 |
|---|---|---|---|---|---|
| Denmark | 2023-08-29 | 2023-09-26 | 2026-02-09 | ||
| France | 2023-08-24 | 2023-09-27 | 2026-02-09 | ||
| Spain | 2023-07-31 | 2024-02-07 | 2026-02-09 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-29 | Denmark | Acceptable 2023-07-14
|
2023-07-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-13 | Denmark | Acceptable 2024-01-15
|
2024-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-09 | Denmark | Acceptable 2024-11-05
|
2024-11-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-14 | Denmark | Acceptable 2024-11-05
|
2024-11-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-17 | Denmark | Acceptable 2025-06-02
|
2025-06-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-08 | Denmark | Acceptable 2025-10-10
|
2025-10-10 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-05 | Denmark | Acceptable 2026-01-27
|
2026-01-28 |