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NCT06103838 · ClinicalTrials.gov registry record · Phase 2

18F-Fluciclovine PET/CT in Multiple Myeloma

A Phase 2 study of Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM), sponsored by National Cancer Institute (NCI).

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: Phase 2
Development phase: 60
Enrollment target: 1
Study location

NCT06103838: Recruiting Phase 2 study of Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM), sponsored by National Cancer Institute (NCI).

NCT06103838 is a Phase 2 study of Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM) that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06103838, a Phase 2 study of Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM), is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status: Phase 2
Development phase: 60 participants
Enrollment target: 1
Study location

Study 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, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.

Primary Outcome

The performance of 18F-fluciclovine PET/CT is assessed by concordance with the 18F-FDG PET/CT imaging in scan positivity. A positive lesion is defined as focal uptake greater than background associated with abnormal CT findings (i.e., lytic bone lesions or extramedullary tissue.) The point estimates and 95% confidence intervals of the concordance rate in scan positivity between 18F-fluciclovine and 18F-FDG PET/CT will be reported.

Conditions Studied

Multiple Myeloma Newly Diagnosed Multiple Myeloma (NDMM) Relapsed and/or Refractory Multiple Myeloma (RRMM)

Interventions

DRUG 18F-fluciclovine injection
PROCEDURE 18F-FDG PET/CT

Study Locations (1)

Maryland

National Institutes of Health Clinical Center - Bethesda

Trial Details

Field	Value
Enrollment Target	60 participants
Start Date	2024-03-25
Est. Completion	2031-12-06
Phase	Phase 2

National Cancer Institute (NCI)

3,257 total trials

What NCT06103838 shows while recruiting

NCT06103838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower).

The record links to 3 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which 18F-fluciclovine injection is the first listed.

NCT06103838 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT06103838 about?

NCT06103838 is a clinical study titled "18F-Fluciclovine PET/CT in Multiple Myeloma". 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, researchers need to find ways to identify returning disease earlier. Objective: To find out if the rad...

What is the current status of trial NCT06103838?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-03-25. Estimated completion is 2031-12-06.

What conditions does trial NCT06103838 study?

This clinical trial studies the following conditions: Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM).

What interventions are being tested in trial NCT06103838?

The interventions under investigation include: 18F-fluciclovine injection (DRUG), 18F-FDG PET/CT (PROCEDURE).

Who is sponsoring clinical trial NCT06103838?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06103838 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06103838's enrollment target sits among peer trials

60 228th of 438 higher than 205 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06103838, the US trial registry maintained by the National Library of Medicine. NCT06103838 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.