18F-Fluciclovine PET/CT in Multiple Myeloma

NCT06103838 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10001525001525-C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

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

Keywords

RRMM; NDMM; 18F-FDG PET/CT; PET/CT; 18F-fluciclovine; Imaging; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.

  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.

  After 50 evaluable participants have completed baseline scans.

Secondary Outcomes (4)

• Evaluate the efficacy of 18F-fluciclovine in measuring disease volume as compared to other indicators of disease volume such as serum M protein, serum free-light chains, urine M protein, B2 microglobulin, and bone marrow plasma cell percentage.

  Between Timepoint #1 and Timepoint #3

• Evaluate the ability of 18F-fluciclovine to identify minimal residual disease (MRD) as compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).

  Between Timepoint #1 and Timepoint #3

• Evaluate the ability for 18F-fluciclovine to evaluate response after treatment as compared to the IMWG response criteria.

  Between Timepoint #1 and Timepoint #3

• Evaluate the safety of 18F-fluciclovine as a radiotracer in patients with multiple myeloma.

  From the time at each 18F-fluciclovine dose through 3 days after each dose.

Study Arms (1)

18F-fluciclovine PET/CT in Multiple Myeloma

EXPERIMENTAL

Evaluate 18F-fluciclovine PET/CT in participants with multiple myeloma at Timepoint #1, Timepoint #2 ( after induction treatment (NDMM) or six months (RRMM)) and at Timepoint #3 (the time of progression or 5 years).

Drug: 18F-fluciclovine injection; Procedure: 18F-FDG PET/CT

Interventions

18F-fluciclovine injection DRUG

370 MBq (10 mCi)(+/-20%) as a bolus intravenous injection.

18F-fluciclovine PET/CT in Multiple Myeloma

18F-FDG PET/CT PROCEDURE

All participants will undergo 18F-FDG PET/CT within 30 days of the 18F-fluciclovine PET/CT scan

18F-fluciclovine PET/CT in Multiple Myeloma

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elizabeth M Hill, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NCI Medical Oncology Referral Office

CONTACT

(240) 760-6050; ncimo_referrals@nih.gov

Elizabeth M Hill, M.D.

CONTACT

(240) 889-5377; elizabeth.hill@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 27, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): December 6, 2031
• Last Updated: May 7, 2026

Record last verified: 2026-02-24

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data will be made available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available upon request and with the permission of the study PI. Genomic data are made available via dbGAP through requests to the data custodians.

Locations

US (1)