Actively Recruiting
A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma
Led by National Cancer Institute (NCI) · Updated on 2026-05-29
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple myeloma (MM) is a cancer of plasma cells that currently has no cure and often returns after treatment. Survival after diagnosis is typically 5 to 8 years. Researchers are evaluating whether the radiotracer 18F-fluciclovine, injected during PET/CT scans, is better at detecting MM than the commonly used 18F-FDG tracer, aiming to improve early detection and treatment decisions. This is a phase 2, open-label study involving adults with newly diagnosed or relapsed/refractory MM. Participants will receive an intravenous injection of 18F-fluciclovine (370 MBq) and undergo PET/CT scans at three key times: before treatment or early in treatment (newly diagnosed MM), six months after initial scans (relapsed/refractory MM), and either at disease progression or after 5 years. Each visit includes both 18F-fluciclovine and 18F-FDG PET/CT scans, an optional MRI, and a bone marrow biopsy from the hip. The study compares the effectiveness of these imaging methods in detecting MM. During the study, participants will have three visits for imaging and biopsies, with tests spread over about 30 days per visit. Blood tests, disease volume measurements, and bone marrow analysis will be performed to assess disease status and treatment response. Safety of 18F-fluciclovine will be monitored up to three days after each dose. Follow-up includes a final visit after 5 years or upon disease progression, allowing long-term monitoring of MM status.
CONDITIONS
Brief Title
18F-Fluciclovine PET/CT in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group criteria
- Newly diagnosed multiple myeloma with serum M-protein ≥ 3 g/dL and/or bone marrow plasma cells ≥ 10% plus at least one of anemia, renal failure, hypercalcemia, bone lesions, or high plasma cells
- Relapsed and/or refractory multiple myeloma with at least 1 prior line of therapy
- Measurable disease defined by monoclonal plasma cells, monoclonal protein in serum or urine, abnormal free light chain ratio, or measurable lesion on imaging
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Negative pregnancy test for women of child-bearing potential
- Agreement to use effective contraception 24 hours before and after each 18F-fluciclovine administration
- Ability and willingness to provide informed consent
You will not qualify if you...
- History of allergic reactions to compounds similar to 18F-FDG or 18F-fluciclovine
- Severe claustrophobia not helped by oral medication or unwilling to take such medication
- Uncontrolled illnesses including psychiatric or social conditions that affect study compliance
- Breastfeeding women who must discontinue breastfeeding until 3 days after 18F-fluciclovine administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive 18F-fluciclovine injections followed by PET/CT scans to evaluate multiple myeloma at three time points: baseline, after induction treatment or 6 months, and at progression or 5 years.
3 imaging visits with 18F-fluciclovine PET/CT and 18F-FDG PET/CT
Duration - From each 18F-fluciclovine dose through 3 days after
Participants are monitored for safety and response after each 18F-fluciclovine dose up to 3 days post-dose.
Safety monitoring after each imaging visit
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
E
Elizabeth M Hill, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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