Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
16
Countries
1
Sites
3
Relapsed/ refractory multiple myeloma
Key facts
- Sponsor
- Cancer Trials Ireland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Nov 2021 → 9 Sep 2025
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516945-37-00
- EudraCT number
- 2019-004386-40
- ClinicalTrials.gov
- NCT04667663
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 |
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cancer Trials Ireland
- Sponsor organisation
- Cancer Trials Ireland
- Address
- Rcsi House, 121 Saint Stephen's Green 121 Saint Stephen's Green
- City
- Dublin 2
- Postcode
- D02 H903
- Country
- Ireland
Scientific contact point
- Organisation
- Cancer Trials Ireland
- Contact name
- Chief Operations Officer
Public contact point
- Organisation
- Cancer Trials Ireland
- Contact name
- Chief Operations Officer
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Ended | 16 | 3 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Ireland | 2021-11-04 | 2025-09-09 | 2021-11-23 | 2023-05-23 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-25 | Ireland | Acceptable 2024-10-29
|
2024-10-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-13 | Ireland | Acceptable 2025-08-18
|
2025-08-18 |