Clinical trial • Phase II • Oncology|Other
Fluciclovine (18F) for Multiple myeloma
Phase II trial of Fluciclovine (18F) for Multiple myeloma. FDG PET/CT (comparator imaging modality)-controlled. 50 participants.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase II
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 14-11-2024
Trial design
FDG PET/CT (comparator imaging modality)-controlled Phase II trial in Norway.
- Comparator
- FDG PET/CT (comparator imaging modality)
- Target Sample Size
- 50
Eligibility
Recruits 50 Vulnerable populations not selected (isVulnerablePopulationSelected:false). Consent required — "Patients who do not sign the consent for any reason or do not accept the study premises". Subject information and informed consent forms provided for adults (documents: L1_ICF Main Adult CLEAN; L1_ICF Main Adult TC). No assent or parental consent described..
- Vulnerable Population
- Vulnerable populations not selected (isVulnerablePopulationSelected:false). Consent required — "Patients who do not sign the consent for any reason or do not accept the study premises". Subject information and informed consent forms provided for adults (documents: L1_ICF Main Adult CLEAN; L1_ICF Main Adult TC). No assent or parental consent described.
Inclusion criteria
- {"criterion_text":"-Patients who have been enrolled in the REMNANT study Part 2 and who are eligible for FDG PET/CT"}
Exclusion criteria
- {"criterion_text":"-Patients who do not sign the consent for any reason or do not accept the study premises\n-Hypersensitivity to the active substance or to any of the excipients\n-Patients with renal impairment for whom an increased radiation exposure is possible, and the additional potential risk is considered not acceptable"}
Endpoints
Primary endpoints
- {"endpoint_text":"-The number of patients with positive Fluciclovine PET/CT and negative FDG PET/CT and how this correlate to PFS and OS","definition_or_measurement_approach":"Assess positivity on Fluciclovine PET/CT versus FDG PET/CT and determine correlation of these imaging status groups with progression-free survival (PFS) and overall survival (OS)."}
Secondary endpoints
- {"endpoint_text":"-The number of patients with positive Fluciclovine PET/CT and positive FDG PET/CT and how this correlate to PFS and OS\n-The number of patients with negative Fluciclovine PET/CT and positive FDG PET/CT and how this correlate to PFS and OS\n-The number of patients with negative Fluciclovine PET/CT and negative FDG PET/CT and how this correlate to PFS and OS\n-Evaluate the safety of Fluciclovine, by incidence and severity of AEs\n-Determine the agreement between Fluciclovine PET/CT and FDG PET/CT assessments","definition_or_measurement_approach":"Count patients in each imaging-positive/negative category and correlate these categories with PFS and OS; safety assessed by incidence and severity of adverse events (AEs); agreement between Fluciclovine PET/CT and FDG PET/CT assessed by measures of concordance/ agreement (not further specified)."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Planned Sample Size
- 50
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent required. Subject information and informed consent forms provided for adults (documents: L1_ICF Main Adult CLEAN; L1_ICF Main Adult TC). Exclusion includes: "Patients who do not sign the consent for any reason or do not accept the study premises". No assent or parental consent described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
Norway
- Earliest CTIS Part Ii Submission Date
- 01-11-2024
- Latest Decision Or Authorization Date
- 27-05-2025
- Processing Time Days
- 208
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- The Intervention Centre
- Principal Investigator Name
- Mona-Elisabeth Rootwelt-Revheim
- Principal Investigator Email
- monar@ous-hf.no
- Contact Person Name
- Mona-Elisabeth Rootwelt-Revheim
- Contact Person Email
- monar@ous-hf.no
- Number Of Participants
- 50
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- Axumin 1,600 MBq/mL solution for injection
- Active Substance
- Fluciclovine (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Authorised (Marketing authorisation: EU/1/17/1186/001)
- Starting Dose
- 370 MBq
- Dose Levels
- 370 MBq
- Frequency
- Single administration
- Maximum Dose
- 370 MBq
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