Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
68
Countries
6
Sites
16
Multiple myeloma
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Dec 2023 → ongoing
- Decision date (initial)
- 2026-04-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501941-63-00
- ClinicalTrials.gov
- NCT05714839
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
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 10 | 3 |
| Germany | Authorised, recruitment pending | 7 | 5 |
| Greece | Authorised, recruitment pending | 2 | 2 |
| Italy | Authorised, recruitment pending | 3 | 2 |
| Poland | Ongoing, recruiting | 3 | 3 |
| Sweden | Authorised, recruitment pending | 7 | 1 |
| Rest of world
Turkey, Australia, United States, Korea, Republic of, Taiwan, Japan, Mexico, Argentina, United Kingdom, Brazil
|
— | 36 | — |
Investigational sites
Turku University Hospital
Hematology and stem cell transplantation, Hameentie 11, 20520, Turku
Tampere University Hospital
Hematology, Elamanaukio 2, 33520, Tampere
HUS-yhtymae
Cancer center, hematology department, Haartmaninkatu 4, 00290, Helsinki
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie Abt. Onkologie, Hämatologie, Knochenmarktransplantation mit Abt. Pneumologie, Martinistrasse 52, Eppendorf, Hamburg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik für Innere Medizin III Hämatologie und Onkologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Gemeinschaftspraxis Haematologie Onkologie
N/A, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Klinikum Oldenburg AöR
Universitätsklinik für Innere Medizin – Onkologie und Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II Zentrum Innere Medizin (ZIM), Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Athens Medical Center S.A.
Hematology Oncology Department, Pylea, Asklipiou 10, Thessaloniki
General Hospital Of Athens Alexandra
Department of Clinical Therapeutics, Plasma cell dyscrasias unit, Vassilissis Sofias Avenue 80, 115 28, Athens
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Servizio e DH di Ematologia, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
SC Ematologia, Via Francesco Sforza 28, 20122, Milan
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplatologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddzial Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Oddział Hematoonkologii, Transplantacji Szpiku i Chemioterapii, Ul. Stanislawa Staszica 11, 20-081, Lublin
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 |
|---|---|---|---|---|---|
| Poland | 2023-12-13 | 2023-12-13 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-09 | Poland | Acceptable 2023-05-02
|
2023-05-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-05-19 | Poland | Acceptable | 2023-08-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-20 | Poland | Acceptable 2023-11-06
|
2023-11-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-19 | Poland | Acceptable 2023-11-06
|
2024-08-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-30 | Poland | Acceptable 2024-10-28
|
2024-10-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-20 | Poland | Acceptable 2025-03-16
|
2025-03-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-23 | Poland | Acceptable 2025-03-16
|
2025-06-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-08 | Poland | Acceptable 2025-10-26
|
2025-10-29 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2026-01-30 | Acceptable 2025-10-26
|
2026-04-08 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2026-01-30 | Acceptable 2025-10-26
|
2026-04-14 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2026-01-30 | 2026-04-22 | ||
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2026-01-30 | 2026-03-31 | ||
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2026-01-30 | 2026-04-08 | ||
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-28 | 2026-04-28 |