Status:
RECRUITING
18F-Fluciclovine PET/CT in Multiple Myeloma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma
Newly Diagnosed Multiple Myeloma (NDMM)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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, rese...
Detailed Description
Background: * 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 hematologi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 6 2031
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06103838
Start Date
March 25 2024
End Date
December 6 2031
Last Update
December 31 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892