18F-Fluciclovine PET/CT in Multiple Myeloma

• Status: Recruiting
• Trial end date: 2031-12-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorodeoxyglucose F18

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.