Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
82
Countries
4
Sites
4
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
- 16 Nov 2022 → ongoing
- Decision date (initial)
- 2024-07-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505212-38-00
- EudraCT number
- 2022-001204-18
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
4 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 6 | 1 |
| Greece | Ongoing, recruitment ended | 8 | 1 |
| Norway | Ongoing, recruitment ended | 12 | 1 |
| Spain | Ended | 17 | 1 |
| Rest of world
Korea, Republic of, Israel, Australia
|
— | 39 | — |
Investigational sites
Alexandra Hospital
"Department of Clinical Therapeutics", Vassilissas Sofias Avenue 80, 115 28, Athens
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 | 2024-02-26 | 2025-01-24 | 2024-09-11 | 2024-09-11 | |
| Greece | 2022-11-16 | 2022-11-24 | 2024-06-25 | ||
| Norway | 2023-06-14 | 2023-09-11 | 2024-10-28 | ||
| Spain | 2023-03-14 | 2025-12-15 | 2023-11-23 | 2024-01-22 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-05 | Denmark | Acceptable 2024-07-01
|
2024-07-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-22 | Denmark | Acceptable 2024-07-01
|
2024-08-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-14 | Denmark | Acceptable 2024-07-01
|
2024-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-06 | Denmark | Acceptable 2025-02-14
|
2025-02-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-14 | Denmark | Acceptable 2025-06-20
|
2025-06-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-17 | Denmark | Acceptable 2025-06-20
|
2025-07-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-08-08 | Denmark | Acceptable 2025-06-20
|
2025-08-08 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-17 | Denmark | Acceptable 2025-06-20
|
2025-10-17 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-18 | Acceptable 2026-02-26
|
2026-03-02 |