Using 18F-fluciclovine PET/CT to detect multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the radiotracer 18F-fluciclovine in detecting multiple myeloma compared to the currently used 18F-FDG PET/CT. Participants, aged 18 and older with either newly diagnosed or relapsed multiple myeloma, will undergo imaging scans after receiving an injection of the radiotracer. The study will involve screening, blood tests, and three study visits to assess the concordance between the two imaging methods. The goal is to improve early detection of relapsed disease to enhance treatment outcomes.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Elizabeth M Hill, M.D. — National Cancer Institute (NCI)
• Study coordinator: NCI Medical Oncology Referral Office
• Email: ncimo_referrals@nih.gov
• Phone: (240) 760-6050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.