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
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INCLUSION CRITERIA:
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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
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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
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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
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Age >=18 years.
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ECOG performance status <= 2
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Negative serum or urine pregnancy test at screening for WOCBP.
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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.
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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.
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
April 14 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892