18F-Fluciclovine PET/CT in Multiple Myeloma

Launched by NATIONAL CANCER INSTITUTE (NCI) · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method using a substance called 18F-fluciclovine to see if it can better detect multiple myeloma (MM), a type of blood cancer, compared to the current method using 18F-FDG. Early detection of MM, especially when it comes back after treatment, is important for improving patient outcomes. The trial is open to adults aged 18 and older who have been diagnosed with either newly diagnosed multiple myeloma or relapsed/refractory multiple myeloma, which means their cancer has returned or did not respond to previous treatments.

Participants in the trial will have several visits over a few months where they will undergo blood tests, imaging scans (PET/CT), and a bone marrow biopsy, which is a test to check the bone marrow for cancer cells. The scans will use both 18F-FDG and 18F-fluciclovine to see which one is more effective at spotting the cancer. The study lasts for up to five years, depending on the individual’s disease progression. It's important for participants to be in good overall health and meet specific criteria, such as having measurable disease, to join the trial. If you’re interested or think you might qualify, it's a good idea to discuss this with your healthcare provider for more information.

Gender

ALL

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.