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.
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
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.
Single group
18F-fluciclovine injection
Drug370 MBq (10 mCi)(+/-20%) as a bolus intravenous injection.
18F-FDG PET/CT
Procedure/SurgeryAll participants will undergo 18F-FDG PET/CT within 30 days of the 18F-fluciclovine PET/CT scan
To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.
The performance of 18F-fluciclovine PET/CT is assessed by concordance with the 18F-FDG PET/CT imaging in scan positivity. A positive lesion is defined as focal uptake greater than background associated with abnormal CT findings (i.e., lytic bone lesions or extramedullary tissue.) The point estimates and 95% confidence intervals of the concordance rate in scan positivity between 18F-fluciclovine and 18F-FDG PET/CT will be reported.
Evaluate the efficacy of 18F-fluciclovine in measuring disease volume as compared to other indicators of disease volume such as serum M protein, serum free-light chains, urine M protein, B2 microglobulin, and bone marrow plasma cell percentage.
Disease volumes measured by 18F-fluciclovine will be correlated with other indicators of disease volume such as serum M protein, serum free-light chains, urine M protein, B2 microglobulin, and bone marrow plasma cell percentage by Spearman rank correlation.
Evaluate the ability of 18F-fluciclovine to identify minimal residual disease (MRD) as compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).
Status of minimal residual disease (MRD) identified by 18F-fluciclovine will be compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).
Evaluate the ability for 18F-fluciclovine to evaluate response after treatment as compared to the IMWG response criteria.
Response after treatment determined by 18F-fluciclovine will be compared to the IMWG response criteria by McNemar test.
Evaluate the safety of 18F-fluciclovine as a radiotracer in patients with multiple myeloma.
All participants will be evaluable for toxicity from the time at each 18F-fluciclovine dose through 3 days after each dose. Safety of the agents will be assessed by determining the type, grade, and frequency of adverse events noted in each participant who receives at least one dose of each of the study treatments. Safety data will be presented in a summary.
Click on the lead sponsor to view all of their trials.
