Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
43
Countries
1
Sites
7
Multiple Myeloma
Key facts
- Sponsor
- University Medical Center Hamburg-Eppendorf
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 28 Jun 2023 → ongoing
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511794-30-00
- EudraCT number
- 2021-001413-37
- ClinicalTrials.gov
- NCT05853965
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Medical Center Hamburg-Eppendorf
- Sponsor organisation
- University Medical Center Hamburg-Eppendorf
- Address
- Martinistrasse 52, Eppendorf Eppendorf
- City
- Hamburg
- Postcode
- 20251
- Country
- Germany
Scientific contact point
- Organisation
- University Medical Center Hamburg-Eppendorf
- Contact name
- Prof. Dr. med. Katja Weisel
Public contact point
- Organisation
- University Medical Center Hamburg-Eppendorf
- Contact name
- Prof. Dr. med. Katja Weisel
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 43 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Flemmingstrasse 4, Altendorf, Chemnitz
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
University Medical Center Hamburg-Eppendorf
II. Medical Clinic & Polyclinic, Oncology, Heamatology, BMT, Pneumology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsmedizin Greifswald KöR
Klinik und Poliklinik für Innere Medizin C, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Charite Research Organisation GmbH
Medizinische Klinik, Haematologie/Onkologie, Tumorimmunologie, Hamato Onkologische Phase-I Unit, Hindenburgdamm 30, Berlin
Universitaetsklinikum Heidelberg AöR
Klinik für Hämatologie, Onkologie, Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
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 | 2023-06-28 | 2024-01-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | Germany | Acceptable 2024-10-15
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-26 | Germany | Acceptable 2025-07-31
|
2025-08-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-03 | Germany | Acceptable | 2025-12-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-27 | Germany | Acceptable | 2026-03-27 |