Multiple MyelomaPhase 2NCT06103838
18F-Fluciclovine PET/CT in Multiple Myeloma
A Phase 2 study testing 18F-fluciclovine injection and 18F-FDG PET/CT in people with Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NDMM), run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- 18F-fluciclovine injection and 18F-FDG PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 6 Dec 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- >= 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NCI Medical Oncology Referral Office, 240-760-6050, ncimo_referrals@nih.gov
About this study
Official title: A Phase II Trial Evaluating 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.
Read more
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.
Read the detailed description
Background:
- Multiple myeloma (MM) is an incurable malignancy of plasma cells that leads to destructive bone lesions, renal damage, anemia, and hypercalcemia. MM is the second most common hematologic malignancy. The American Cancer Society estimates that annually over 34,000 new cases of MM will occur in the U.S. and over 12,000 deaths due to MM in 2022.
- Overall survival (OS) has improved significantly over the past 20 years with the development of proteasome inhibitors (PIs), immunomodulatory agents (IMiDs) and anti-CD38 monoclonal antibodies. However, despite these advances, patients ultimately relapse requiring multiple subsequent lines of therapy. As MM evolves, it generally becomes more refractory, and patients ultimately succumb to their disease.
- With multiple lines of efficacious therapies, the correct early identification of relapsed disease is important to trigger initiation of a new line of therapy.
- Limitations in conventional imaging highlight a need for molecular imaging agents with better sensitivity for detecting and measuring tumor burden to improve staging and treatment selection for patients with MM and plasma cell dyscrasias.
- 18F-fluciclovine is a radionuclide approved by the FDA for evaluating suspected prostate cancer recurrence but has shown additional ability in detecting MM lesions.
Objective:
To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma
Eligibility:
- Participants >= 18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2
- Participants must have a documented diagnosis of MM defined by the International Myeloma Working Group (IMWG) Criteria
- Participants fit criteria for one of the following categories:
- Newly diagnosed multiple myeloma (NDMM) without previous treatment (or within the first 3 cycles of front-line treatment)
- Relapsed and/or Refractory multiple myeloma (RRMM) with at least 1 prior line of therapy
Design:
This is an open-label, single center phase 2 study evaluating 18F-fluciclovine PET/CT imaging in up to 50 participants with multiple myeloma. Participants will be enrolled into one of two cohorts based on disease status; newly diagnosed multiple myeloma (NDMM) participants will be enrolled into Cohort 1 and relapsed refractory multiple myeloma (RRMM) participants will be enrolled into Cohort 2. All subjects will undergo an 18F-fluciclovine injection followed by a static whole-body PET/CT at three time points: Timepoint #1, Timepoint #2 (after induction for NDMM or at 6 months for RRMM) and Timepoint #3 (at progression or at 5 years). Results will be compared to 18F-FDG PET/CT imaging at those same timepoints.
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM)
- Being tested
- 18F-fluciclovine injection, 18F-FDG PET/CT
- Keywords
- RRMM, NDMM, 18F-FDG PET/CT, PET/CT, 18F-fluciclovine, Imaging, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovine injectionDrug
370 MBq (10 mCi)(+/-20%) as a bolus intravenous injection.
18F-FDG PET/CTProcedure or surgery
All participants will undergo 18F-FDG PET/CT within 30 days of the 18F-fluciclovine PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 18F-fluciclovine injection; Procedure: 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Disease volumes measured by 18F-fluciclovine will be correlated with 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 by Spearman rank correlation.
Measured: 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).
Status of minimal residual disease (MRD) identified by 18F-fluciclovine will be compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).
Measured: Between Timepoint #1 and Timepoint #3
Evaluate the ability for 18F-fluciclovine to evaluate response after treatment as compared to the IMWG response criteria.
Response after treatment determined by 18F-fluciclovine will be compared to the IMWG response criteria by McNemar test.
Measured: Between Timepoint #1 and Timepoint #3
Evaluate the safety of 18F-fluciclovine as a radiotracer in patients with multiple myeloma.
All participants will be evaluable for toxicity from the time at each 18F-fluciclovine dose through 3 days after each dose. Safety of the agents will be assessed by determining the type, grade, and frequency of adverse events noted in each participant who receives at least one dose of each of the study treatments. Safety data will be presented in a summary.
Measured: From the time at each 18F-fluciclovine dose through 3 days after each dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start25 Mar 2024
- Primary completion6 Dec 2027 (estimated)
- Study completion6 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth M Hill, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103838
- Sponsor's protocol ID
- 10001525
- Other IDs
- 001525-C
- Status last verified
- 13 Oct 2026
- First submitted
- 26 Oct 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.