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 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.

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