Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
2
Sites
3
Multiple Myeloma, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma.
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Jun 2023 → 4 Jun 2025
- Decision date (initial)
- 2023-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501855-97-00
- WHO UTN
- U1111-1282-2472
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Myeloma, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10067070 | Follicular B-cell non-Hodgkin's lymphoma | 10029104 |
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 1 | 2 |
| Netherlands | Ended | 5 | 1 |
| Rest of world
Canada, Japan
|
— | 2 | — |
Investigational sites
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Institut Paoli-Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Amsterdam UMC
Hematology, Meibergdreef 9, 1105 AZ, Amsterdam
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 |
|---|---|---|---|---|---|
| France | 2023-06-29 | 2025-06-04 | 2023-07-06 | 2023-09-28 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-14 | France | Acceptable 2023-06-06
|
2023-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-10 | France | Acceptable | 2023-09-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-19 | France | Acceptable 2024-03-11
|
2024-03-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-11 | France | Acceptable 2024-03-11
|
2024-07-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-07-15 | France | Acceptable 2024-03-11
|
2024-07-15 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-10-10 | Acceptable 2024-03-11
|
||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2024-12-20 | France | Acceptable 2024-03-11
|
2024-12-20 |