Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
121
Countries
5
Sites
13
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
- 4 Mar 2020 → ongoing
- Decision date (initial)
- 2024-02-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507060-39-00
- EudraCT number
- 2019-003047-30
- ClinicalTrials.gov
- NCT04091126
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Myeloma
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
5 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 5 | 1 |
| Germany | Authorised, recruitment pending | 9 | 2 |
| Italy | Ended | 6 | 2 |
| Poland | Ongoing, recruitment ended | 26 | 2 |
| Spain | Ended | 21 | 6 |
| Rest of world
United States, Canada, Korea, Republic of, Australia
|
— | 54 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
Service d’Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Gemeinschaftspraxis Haematologie Onkologie
NA, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Divisione di Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Istituto di Ematologia Seragnoli, Via Pietro Albertoni 15, 40138, Bologna
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Oddział Hematologii, Transplantacji Szpiku i Chemioterapii, Ul. Stanislawa Staszica 11, 20-081, Lublin
Hospital Universitario Virgen De La Victoria
Hematología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Quironsalud Madrid
Hematología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Marques De Valdecilla
Hematología, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Hematología, Carretera Canyet S/n, 08916, Badalona
Hospital Clinic De Barcelona
Hematología, Calle Villarroel 170, 08036, Barcelona
Clinica Universidad De Navarra
Hematología, Avenue Pio XII 36, 31008, Pamplona
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 | 2020-03-04 | 2025-06-02 | 2021-03-08 | ||
| Italy | 2020-05-12 | 2024-06-03 | 2020-06-04 | 2024-06-03 | |
| Poland | 2021-06-02 | 2021-06-07 | 2024-06-03 | ||
| Spain | 2020-03-06 | 2025-06-02 | 2020-05-18 | 2024-06-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | Poland | Acceptable 2024-02-23
|
2024-02-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-27 | Poland | Acceptable 2024-02-23
|
2024-06-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-07 | Poland | Acceptable 2025-02-08
|
2025-02-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-20 | Poland | Acceptable 2025-10-03
|
2025-10-06 |