NCT06103838RecruitingPhase 2

18F-Fluciclovine PET/CT in Multiple Myeloma

A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 26 Oct 2023
Start date: 25 Mar 2024
Primary completion date: 6 Dec 2027
Lead sponsor: National Cancer Institute (NCI)
Diseases: Multiple myeloma
NCT number: NCT06103838

What you commit to

Study type: Interventional · Phase 2
Planned participants: 60
From 25 Mar 2024 to the primary completion date, 6 Dec 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.

Other illness

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.

Other

Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.

Criteria the registry did not label

INCLUSION CRITERIA:
Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \>= 3 g/dL and/or bone marrow plasma cells \>= 10% and at least one of the following:
- Anemia: Hemoglobin \<=10 g/dL, or
- Renal Failure: serum creatinine \>= 2.0 mg/dL, or
- Hypercalcemia: Ca \>= 10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or PET/CT, or
- \>= 2 focal lesions on spinal MRI, or
- \>= 60% bone marrow plasma cells, or
- Involved/un-involved serum free light chain ration \>= 100
Participants must have measurable disease defined by any one of the following:
- Monoclonal bone marrow plasma cells \> 5%
- Serum monoclonal protein \>= 0.2 g/dl
- Urine monoclonal protein \> 200 mg/24 hr
- Serum immunoglobulin free light chain \> 10 mg/dL AND abnormal kappa/lambda ratio
- A measurable lesion on PET/CT or MRI
Participants fit criteria for one of the following categories:
- Newly diagnosed multiple myeloma (NDMM)
- Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy
Age \>=18 years.
ECOG performance status \<= 2
Negative serum or urine pregnancy test at screening for WOCBP.
Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.
Ability of subject to understand and the willingness to sign a written informed consent document.

Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.