Clinical Trial Finder

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 patient's ability to comply with study procedures or interfere with the safety of the investigational regimen.

• - Patients who have received the same antibody (YS5) earlier as part of therapy or detection.

• - 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

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.

Arms

Experimental: Cohort A ([89Zr]DFO-YS5, single scan

Participants receive [89Zr]DFO-YS5 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

Experimental: Cohort B ([89Zr]DFO-YS5, multiple scans

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

Interventions

Drug: - Zirconium Zr 89-DFO-YS5

Given IV

Procedure: - Positron Emission Tomography / Computed Tomography (PET/CT)

Positron emission tomography-computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography scanner and an x-ray computed tomography scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed image

Procedure: - Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)

Positron emission tomography-magnetic resonance imaging is a hybrid imaging technology that incorporates magnetic resonance imaging soft tissue morphological imaging and positron emission tomography functional imaging.

Other: - Fludeoxyglucose F-18

Given IV