Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
205
Countries
1
Sites
2
Multiple Myeloma (MM)
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
- 13 Jul 2020 → 7 Jan 2026
- Decision date (initial)
- 2024-02-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502053-34-00
- EudraCT number
- 2018-001041-13
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Myeloma (MM)
| 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
- 94080-4990
- 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
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 20 | 2 |
| Rest of world
Australia, United States, Canada
|
— | 185 | — |
Investigational sites
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 | 2020-07-13 | 2025-07-10 | 2020-10-19 | 2024-08-06 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Spain | Acceptable 2024-02-27
|
2024-02-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-08 | Spain | Acceptable 2024-06-21
|
2024-06-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-14 | Spain | Acceptable 2024-06-21
|
2024-08-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-15 | Spain | Acceptable 2024-06-21
|
2024-10-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-13 | Spain | Acceptable 2025-04-25
|
2025-04-28 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-06 | Spain | Acceptable 2025-04-25
|
2025-08-06 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-30 | Spain | Acceptable 2025-04-25
|
2025-10-30 |