18F-Fluciclovine PET/CT in Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.


  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Elizabeth M Hill, M.D.
Principal Investigator Affiliation National Cancer Institute (NCI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM)
Study Website: View Trial Website
Additional Details


  • - Multiple myeloma (MM) is an incurable malignancy of plasma cells that leads to destructive bone lesions, renal damage, anemia, and hypercalcemia.
MM is the second most common hematologic malignancy. The American Cancer Society estimates that annually over 34,000 new cases of MM will occur in the U.S. and over 12,000 deaths due to MM in 2022.
  • - Overall survival (OS) has improved significantly over the past 20 years with the development of proteasome inhibitors (PIs), immunomodulatory agents (IMiDs) and anti-CD38 monoclonal antibodies.
However, despite these advances, patients ultimately relapse requiring multiple subsequent lines of therapy. As MM evolves, it generally becomes more refractory, and patients ultimately succumb to their disease.
  • - With multiple lines of efficacious therapies, the correct early identification of relapsed disease is important to trigger initiation of a new line of therapy.
  • - Limitations in conventional imaging highlight a need for molecular imaging agents with better sensitivity for detecting and measuring tumor burden to improve staging and treatment selection for patients with MM and plasma cell dyscrasias.
  • - 18F-fluciclovine is a radionuclide approved by the FDA for evaluating suspected prostate cancer recurrence but has shown additional ability in detecting MM lesions.
Objective: To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma. Eligibility:
  • - Participants >= 18 years old.
  • - Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
  • - Participants must have a documented diagnosis of MM defined by the International Myeloma Working Group (IMWG) Criteria.
  • - Participants fit criteria for one of the following categories: - Newly diagnosed multiple myeloma (NDMM) without previous treatment (or within the first 3 cycles of front-line treatment) - Relapsed and/or Refractory multiple myeloma (RRMM) with at least 1 prior line of therapy.
Design: This is an open-label, single center phase 2 study evaluating 18F-fluciclovine PET/CT imaging in up to 55 participants with multiple myeloma. Participants will be enrolled into one of two cohorts based on disease status; newly diagnosed multiple myeloma (NDMM) participants will be enrolled into Cohort 1 and relapsed refractory multiple myeloma (RRMM) participants will be enrolled into Cohort 2. All subjects will undergo an 18F-fluciclovine injection followed by a static whole-body PET/CT at three time points: Timepoint #1, Timepoint #2 (after induction for NDMM or at 6 months for RRMM) and Timepoint #3 (at progression or at 5 years). Results will be compared to 18F-FDG PET/CT imaging at those same timepoints.

Arms & Interventions


Experimental: 18F-fluciclovine PET/CT in Multiple Myeloma

Evaluate 18F-fluciclovine PET/CT in participants with multiple myeloma at Timepoint #1, Timepoint #2 ( after induction treatment (NDMM) or six months (RRMM)) and at Timepoint #3 (the time of progression or 5 years).


Drug: - 18F-fluciclovine injection

370 MBq (10 mCi)(+/-20%) as a bolus intravenous injection.

Procedure: - 18F-FDG PET/CT

All participants will undergo 18F-FDG PET/CT within 30 days of the 18F-fluciclovine PET/CT scan

Contact a Trial Team

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Bethesda, Maryland




National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

NCI Medical Oncology Referral Office