New scan could spot hidden myeloma earlier
NCT ID NCT06103838
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 16 times
Summary
This phase 2 trial is testing whether a radioactive tracer called 18F-fluciclovine can detect multiple myeloma better than the standard FDG tracer during PET/CT scans. The study will enroll 60 adults with newly diagnosed or relapsed/refractory multiple myeloma. Each participant will receive both types of scans, along with optional MRI and bone marrow biopsies, to compare how well each tracer spots the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-fluciclovine (a radioactive tracer injected for PET/CT imaging)
- What this could lead to
- If successful, this could lead to a more accurate imaging method for detecting multiple myeloma, especially when the disease returns, helping doctors start treatment earlier.
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The new tracer might not prove better than the current standard scan.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?