[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524063":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":21,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":21,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":44,"whyStopped":21,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-fluciclovine PET\u002FCT in Multiple Myeloma","EXPERIMENTAL","Evaluate 18F-fluciclovine PET\u002FCT 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).",[13,14],"Drug: 18F-fluciclovine injection","Procedure: 18F-FDG PET\u002FCT",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","18F-fluciclovine injection","370 MBq (10 mCi)(+\u002F-20%) as a bolus intravenous injection.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","18F-FDG PET\u002FCT","All participants will undergo 18F-FDG PET\u002FCT within 30 days of the 18F-fluciclovine PET\u002FCT scan",[9],[28],{"name":29,"affiliation":30,"role":31},"Elizabeth M Hill, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":21,"email":37},"NCI Medical Oncology Referral Office","CONTACT","(240) 760-6050","ncimo_referrals@nih.gov",{"name":29,"role":35,"phone":39,"phoneExt":21,"email":40},"(240) 889-5377","elizabeth.hill@nih.gov",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-77.10026,38.98067,{"lat":54,"lon":53},[57],{"name":34,"role":35,"phone":58,"phoneExt":21,"email":37},"240-760-6050",{"type":60,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100524063","phase-2-18f-fluciclovine-petct-in-multiple-myeloma-100524063",false,"NCT06103838","18F-Fluciclovine PET\u002FCT in Multiple Myeloma","A Phase II Trial Evaluating 18F-Fluciclovine PET\u002FCT in Multiple Myeloma","* INCLUSION CRITERIA:\n* 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\u002FdL and\u002For bone marrow plasma cells \\>= 10% and at least one of the following:\n\n  * Anemia: Hemoglobin \\\u003C=10 g\u002FdL, or\n  * Renal Failure: serum creatinine \\>= 2.0 mg\u002FdL, or\n  * Hypercalcemia: Ca \\>= 10.5 mg\u002FdL, or\n  * Lytic bone lesions on X-ray, CT, or PET\u002FCT, or\n  * \\>= 2 focal lesions on spinal MRI, or\n  * \\>= 60% bone marrow plasma cells, or\n  * Involved\u002Fun-involved serum free light chain ration \\>= 100\n* Participants must have measurable disease defined by any one of the following:\n\n  * Monoclonal bone marrow plasma cells \\> 5%\n  * Serum monoclonal protein \\>= 0.2 g\u002Fdl\n  * Urine monoclonal protein \\> 200 mg\u002F24 hr\n  * Serum immunoglobulin free light chain \\> 10 mg\u002FdL AND abnormal kappa\u002Flambda ratio\n  * A measurable lesion on PET\u002FCT or MRI\n* Participants fit criteria for one of the following categories:\n\n  * Newly diagnosed multiple myeloma (NDMM)\n  * Relapsed and\u002For refractory multiple myeloma (RRMM) with at least 1 prior line of therapy\n* Age \\>=18 years.\n* ECOG performance status \\\u003C= 2\n* Negative serum or urine pregnancy test at screening for WOCBP.\n* 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.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.\n* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.\n* Uncontrolled intercurrent illness including, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* 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.","ALL","18 Years","120 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Background:\n\nMultiple 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.\n\nObjective:\n\nTo 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.\n\nEligibility:\n\nAdults 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).\n\nDesign:\n\nParticipants 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\u002FCT scan takes images of their body.\n\nAll participants will have 3 study visits. During each visit they will have:\n\nTwo PET\u002FCT scans. One with 18F-FDG, one with 18F-fluciclovine.\n\nAn optional magnetic resonance imaging scan.\n\nA 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.\n\nThese tests may be spread over 30 days for each visit.\n\nNDMM 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.\n\nAll participants will have a third study visit after 5 years or when their disease progresses.",[79,80,81],"Multiple Myeloma","Newly Diagnosed Multiple Myeloma (NDMM)","Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[83,84,24,85,86,87,79],"RRMM","NDMM","PET\u002FCT","18F-fluciclovine","Imaging","2026-06-27",{"date":90,"type":91},"2026-06-30","ACTUAL",{"date":93,"type":91},"2024-03-25",{"date":95,"type":73},"2032-12-06",{"name":30,"class":6},1]