Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
30
Countries
1
Sites
7
Multiple Myeloma
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Jul 2024 → 7 Nov 2025
- Decision date (initial)
- 2024-07-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515650-24-00
- EudraCT number
- 2019-001472-11
- ClinicalTrials.gov
- NCT04309981
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
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Carlos Fernandez de Larrea
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Carlos Fernandez de Larrea
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 30 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Clinic De Barcelona
Haematology, Calle Villarroel 170, 08036, Barcelona
Clinica Universidad De Navarra
Haematology, Pio XII Etorbidea 36, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Haematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Salamanca
Haematology, Paseo De San Vicente 58-182, 37007, Salamanca
University Clinical Hospital Virgen De La Arrixaca
Haematology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Complexo Hospitalario Universitario De Santiago
Haematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario 12 De Octubre
Haematology, Bloque D, Avenida De Cordoba Sn, Madrid
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 | 2024-07-26 | 2025-11-07 | 2024-07-26 | 2024-07-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Spain | Acceptable 2024-07-26
|
2024-07-26 |