Overview
Sponsor-declared trial summary
multiple myeloma
To detect the number of patients in the REMNANT study who are positive with Fluciclovine PET/CT and negative with FDG PET/CT and determine how this correlate to PFS and OS
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 18 Dec 2023 → ongoing
- Decision date (initial)
- 2024-11-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517095-38-00
- EudraCT number
- 2022-003420-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To detect the number of patients in the REMNANT study who are positive with Fluciclovine PET/CT and negative with FDG PET/CT and determine how this correlate to PFS and OS
Secondary objectives 5
- To detect how many patients who have both positive Fluciclovine PET/CT and positive FDG PET/CT and determine how this correlate to PFS and OS
- To detect how many patients who have negative Fluciclovine PET/CT and positive FDG PET/CT and determine how this correlate to PFS and OS
- To detect how many patients who have negative Fluciclovine PET/CT and negative FDG PET/CT and determine how this correlate to PFS and OS
- To investigate safety of Fluciclovine
- Compare positive/negative Fluciclovine PET/CT and positive/negative FDG PET/CT statuses
Conditions and MedDRA coding
multiple myeloma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients who have been enrolled in the REMNANT study Part 2 and who are eligible for FDG PET/CT
Exclusion criteria 3
- Patients who do not sign the consent for any reason or do not accept the study premises
- Hypersensitivity to the active substance or to any of the excipients
- Patients with renal impairment for whom an increased radiation exposure is possible, and the additional potential risk is considered not acceptable
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The number of patients with positive Fluciclovine PET/CT and negative FDG PET/CT and how this correlate to PFS and OS
Secondary endpoints 5
- The number of patients with positive Fluciclovine PET/CT and positive FDG PET/CT and how this correlate to PFS and OS
- The number of patients with negative Fluciclovine PET/CT and positive FDG PET/CT and how this correlate to PFS and OS
- The number of patients with negative Fluciclovine PET/CT and negative FDG PET/CT and how this correlate to PFS and OS
- Evaluate the safety of Fluciclovine, by incidence and severity of AEs
- Determine the agreement between Fluciclovine PET/CT and FDG PET/CT assessments
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Axumin 1,600 MBq/mL solution for injection
PRD5128065 · Product
- Active substance
- Fluciclovine (18F)
- Substance synonyms
- Fluciclovine F18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 370 MBq megabecquerel(s)
- Max total dose
- 370 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX12 — -
- Marketing authorisation
- EU/1/17/1186/001
- MA holder
- BLUE EARTH DIAGNOSTICS IRELAND LTD
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Mona-Elisabeth Rootwelt-Revheim
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Caroline Stokke
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 50 | 1 |
| 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 |
|---|---|---|---|---|---|
| Norway | 2023-12-18 | 2023-12-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-2024-2024-517095-38-00_TC | 4 |
| Protocol (for publication) | D1_Protocol EU CT 2024-517095-38-00 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult CLEAN | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult TC | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Axumin | 1 |
| Synopsis of the protocol (for publication) | Local_languange_synopsis | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Norway | Acceptable 2024-11-13
|
2024-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-06 | Norway | Acceptable 2025-05-23
|
2025-05-27 |