This study is currently recruiting participants.
Number
001525-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Fetuses;Neonates
Keywords
RRMM; NDMM; 18F-FDG PET/CT; PET/CT; 18F-fluciclovine; Imaging; Multiple Myeloma
Recruitment Keyword(s)
None
Condition(s)
Multiple Myeloma; Newly diagnosed multiple myeloma (NDMM); Relapsed and/or refractory multiple myeloma (RRMM)
Investigational Drug(s)
Axumin (fluciclovine F18)
Investigational Device(s)
Intervention(s)
Drug: 18F-fluciclovine injection Procedure/Surgery: 18F-FDG PET/CT
Supporting Site
National Cancer Institute
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.
--Back to Top--
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 understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -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.
-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.
EXCLUSION CRITERIA:
-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.
Principal Investigator
Referral Contact
For more information: