Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
4
Countries
1
Sites
4
Multiple myeloma
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Apr 2022 → 19 Jun 2024
- Decision date (initial)
- 2023-07-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505079-65-00
- EudraCT number
- 2020-005968-64
- WHO UTN
- U1111-1262-7139
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
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
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 2 | 4 |
| Rest of world
Canada
|
— | 2 | — |
Investigational sites
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Marques De Valdecilla
Hematology, 5 Planta, Avenida Valdecilla S/n, Santander
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 |
|---|---|---|---|---|---|
| Spain | 2022-04-01 | 2022-07-28 | 2024-01-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-30 | Spain | Acceptable 2023-07-10
|
2023-07-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-01 | Spain | Acceptable 2024-01-15
|
2024-01-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-02 | Spain | Acceptable 2024-01-15
|
2024-07-02 |