imaging study of [89zr]dfo-ys5 for detecting cd46 positive malignancy in multiple myeloma

Conditions: Multiple Myeloma; Plasma Cell Myeloma

Summary: this phase i trial tests the safety of \[89zr\]dfo-ys5 positron emission tomography (pet) imaging and how well it works to detect cd46 positive cancer cells in patients with multiple myeloma. \[89zr\]dfo-ys5 is an imaging agent called a radiopharmaceutical tracer. a radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. \[89zr\]dfo-ys5 targets a specialized protein called cd46, which is in certain multiple myeloma cancer cells, and \[89zr\]dfo-ys5 pet scans may improve detection of multiple myeloma.

primary objective: i. to determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium zr 89-dfo-ys5 (\[89zr\]dfo-ys5 pet, as compared with fludeoxyglucose f-18 (18f-fdg) pet imaging. secondary objectives: i. to determine the safety of \[89zr\]dfo-ys5. ii. to determine the average organ uptake of \[89zr\]dfo-ys5. iii. to descriptively report the patterns of intra-tumoral uptake of \[89zr\]dfo-ys5 on whole body pet, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal. iv. to calculate the dosimetry of \[89zr\]dfo-ys5 in patients with multiple myeloma. exploratory objective: i. to determine the association between uptake (standardized uptake value maximum \[suvmax\]) of \[89zr\]dfo-ys5 with 1q amplification by fluorescence in situ hybridization (fish) on tumor biopsies (when available; fish may be conducted as part of routine, standard-of-care). outline: participants are assigned to 1 of 2 cohorts based on participant preference. cohort a: participants receive \[89zr\]dfo-ys5 intravenously (iv) and undergo a single pet/ct or pet/mri scan 5-7 days post-injection. participants also receive fludeoxyglucose f-18 iv and undergo pet/ct or pet/mri scan within 28 days prior to day 1. cohort b: participants receive \[89zr\]dfo-ys5 iv and undergo four pet/ct or pet/mri scans on days 1, 2, 3-4, and 5-7 post-injection. participants also receive fludeoxyglucose f-18 iv and undergo pet/ct or pet/mri scan within 28 days prior to day 1. patients are followed up at 30 days after final scan.

Eligibility criteria:
inclusion criteria: * participants must have histologically or cytologically confirmed multiple myeloma by international myeloma working group (imwg) diagnostic criteria * at least one positive myelomatous lesion found on 18f-fdg pet/ct or pet/mri. a positive lesion is defined as uptake greater than liver on fdg pet, based on the italian myeloma criteria for pet use (impetus) criteria * age \>= 18 years * total bilirubin =\< 1.5 x institutional upper limit of normal (uln) * aspartate aminotransferase (ast) =\< 3 x uln * alanine aminotransferase (alt) =\< 3 x uln * creatinine clearance \>= 60 ml/min, calculated using the cockcroft-gault equation * ability to understand a written informed consent document, and the willingness to sign it exclusion criteria: * any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen * individuals who are pregnant or breastfeeding/chestfeeding. * - breast-feeding/chest-feeding should be discontinued before administration of \[89zr\]dfo-ys5. * females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of \[89zr\]-dfo-ys5. * - if the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. in such cases, the individual must be excluded from participation if the serum pregnancy result is positive. * - a female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state ( \>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). * individuals who are pregnant or breastfeeding/chestfeeding are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with \[89zr\]-dfo-ys5