Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
55
Countries
2
Sites
8
Relapsed or Refractory Multiple Myeloma (R/R MM)
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
- 28 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-14
- 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
Relapsed or Refractory Multiple Myeloma (R/R MM)
| 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
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Not authorised | 15 | 6 |
| Germany | Ongoing, recruitment ended | 15 | 2 |
| Rest of world
Japan, Israel, United States
|
— | 25 | — |
Investigational sites
Hospices Civils De Lyon
Département Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Nantes
Département Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Montpellier
Département Hématologie Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Institut Universitaire Du Cancer Toulouse-Oncopole
Département Oncologie Médicale - Unité de phase précoce, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Poitiers
Service d'Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
Unité Hémopathies Lymphoïdes, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Goethe University Frankfurt
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
University Medical Center Hamburg-Eppendorf
N/A, Martinistrasse 52, Eppendorf, Hamburg
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 | 2024-06-28 | 2024-11-28 | 2026-02-27 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-17 | France | Acceptable 2024-05-06
|
2024-05-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-29 | Acceptable 2024-11-12
|
2024-11-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-18 | Acceptable 2025-07-17
|
2025-07-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-12 | Acceptable 2025-10-29
|
2025-10-31 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-05 | Acceptable 2026-01-23
|
2026-01-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-24 | Acceptable | 2026-04-20 |