Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
150
Countries
3
Sites
7
Relapsed and/or Refractory 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
- 27 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506003-26-00
- WHO UTN
- U1111-1295-5723
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and/or Refractory Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
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
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 8 | 1 |
| Germany | Ongoing, recruiting | 24 | 3 |
| Spain | Ongoing, recruiting | 18 | 3 |
| Rest of world
United States
|
— | 100 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Innere Medizin V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II ZIM Haus A4, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University Hospital Cologne AöR
Klinik für Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
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 | 2024-12-10 | 2025-03-10 | |||
| Germany | 2024-11-27 | 2025-01-21 | |||
| Spain | 2024-12-18 | 2024-12-18 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-06 | Spain | Acceptable with conditions 2024-11-18
|
2024-11-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-26 | Spain | Acceptable with conditions 2024-11-18
|
2024-11-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-26 | Acceptable with conditions | 2024-12-04 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-18 | Spain | Acceptable with conditions | 2024-12-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-28 | Spain | Acceptable with conditions | 2025-01-28 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-28 | Spain | Acceptable with conditions | 2025-01-28 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-01-28 | Spain | Acceptable with conditions | 2025-01-28 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-05-05 | Spain | Acceptable with conditions | 2025-05-05 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-16 | Spain | Acceptable 2025-08-11
|
2025-08-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-11-11 | Spain | Acceptable 2025-08-11
|
2025-11-11 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-18 | Spain | Acceptable 2026-03-09
|
2026-03-10 |