Home › Multiple Myeloma › NCT06103838
18F-Fluciclovine PET/CT in Multiple Myeloma
A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma
Who can join
Ages 18 to 120 · All sexes
Full eligibility criteria
* 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. EXCLUSION CRITERIA: * 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. * Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them. * Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements. * 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.
About the study
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.
What is being tested
- 18F-fluciclovine injection (drug)
- 18F-FDG PET/CT (procedure)
Sponsor: National Cancer Institute (NCI) · Participants: 60 · Started: Mar 25, 2024
Contact the study team
- NCI Medical Oncology Referral Office · Phone: (240) 760-6050
- Elizabeth M Hill, M.D. · Phone: (240) 889-5377
Official record on ClinicalTrials.gov — NCT06103838
Locations in the U.S.
| Maryland | National Institutes of Health Clinical Center, Bethesda |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.