RECRUITING

18F-Fluciclovine PET/CT in Multiple Myeloma

Conditions

Multiple Myeloma Newly Diagnosed Multiple Myeloma (NDMM)Relapsed and/or Refractory Multiple Myeloma (RRMM)RRMM NDMM 18F-FDG PET/CT PET/CT 18F-fluciclovine Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma

Quick Facts

Study Start:2024-03-25

Study Completion:2031-12-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06103838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Elizabeth M Hill, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Elizabeth M Hill, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25

Study Completion Date2031-12-06

Study Record Updates

Study Start Date2024-03-25

Study Completion Date2031-12-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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