Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
3
Sites
14
Relapsed/Refractory Multiple Myeloma
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Jun 2022 → 10 Jul 2024
- Decision date (initial)
- 2024-04-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-510644-31-00
- EudraCT number
- 2021-003295-13
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory 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
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 10 | 2 |
| Norway | Ended | 16 | 1 |
| Spain | Ended | 24 | 11 |
| Rest of world
Australia
|
— | 10 | — |
Investigational sites
Odense University Hospital
Hematological Research Unit, J B Winsloews Vej 4, 5000, Odense C
Lillebaelt Hospital
Department of Hematology, Beriderbakken 4, 7100, Vejle
Hospital Universitari Vall D Hebron
Servicio de Hematologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Germans Trias I Pujol
Servicio de Hematologia, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario De La Princesa
Servicio de Hematologia, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Y Politecnico La Fe
Servicio de Hematologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital De La Santa Creu I Sant Pau
Servicio de Hematologia, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Servicio de Hematologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Servicio de Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Servicio de Hematología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Quironsalud Madrid
Servicio de Hematología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Institut Catala D'oncologia
Servicio de Hematologia, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario De Salamanca
Servicio de Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
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 |
|---|---|---|---|---|---|
| Denmark | 2023-11-16 | 2024-05-14 | 2024-01-08 | 2024-03-20 | |
| Norway | 2022-06-10 | 2024-03-20 | 2022-08-10 | 2024-03-20 | |
| Spain | 2022-10-10 | 2024-04-09 | 2023-09-28 | 2024-03-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-06 | Norway | Acceptable 2024-04-17
|
2024-04-17 |