18F-Fluciclovine PET/CT in Multiple Myeloma (NCT06103838) | Clinical Trial Compass
RecruitingPhase 2
18F-Fluciclovine PET/CT in Multiple Myeloma
United States60 participantsStarted 2024-03-25
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 understa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.
Timeframe: After 50 evaluable participants have completed baseline scans.