64Cu-LLP2A for Imaging Multiple Myeloma

Inclusion Criteria:

- Adult patients 18 years of age or older with MM, defined according to International
Myeloma Working Group (IMWG) diagnostic criteria as the presence of ≥ 10% clonal bone
marrow cells, organ damage (hypercalcemia, renal failure, anemia, or bone lesions
[CRAB]) and presence of 60% bone marrow involvement, regardless of CRAB. Evidence of
organ damage: Hypercalcemia [serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the
upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)]. Renal insufficiency: creatinine
clearance <40 mL per minute or serum creatinine >177µmol/L (> 2 mg/dL). Anemia:
hemoglobin value of > 20 g/L below the lowest limit of normal, or a hemoglobin value <
100 g/L. Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or
PET/CT or more than one focal lesion on MRI that is at least 5 mm or greater in size.
Other biomarkers of malignancy: serum free light chain ratio > 100 (Cohort 1 MM group
or cohort 2)

- Healthy Volunteer Subjects: Adult 18 years of age or older with no known hematologic
disorder such as anemia, leukemia, etc. who is considered healthy based on assessment
by PI. (Cohort 1 only).

- Able to give informed consent.

- Does not have any exclusions related to PET/MR imaging: No implanted medical devices
such as: pacemaker, defibrillator, neurostimulator, artificial heart valve, cerebral
aneurysm clips, no accidental exposure to metal fragments.

- If applicable for administration of contrast with MRI imaging subject must have a
calculated GFR of at least 60 mg/mL/1.73 m^2.

- Not currently pregnant or nursing: Subject must be surgically sterile (has had a
documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal
(cessation of menses for more than 1 year), non-lactating, or of childbearing
potential for whom a urine pregnancy test (with the test performed within the 24 hour
period immediately prior to administration of 64Cu-LLP2A) is negative.

Exclusion Criteria:

- Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer, who had (or have) any evidence of the other cancer present within the last 5
years.

- Unable to tolerate up to 90 min of PET/MR imaging per imaging session.

- Not claustrophobic.