64Cu-LLP2A for Imaging Multiple Myeloma

Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:November 20, 2018
End Date:November 30, 2020
Contact:Farrokh Dehdashti, M.D.

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Early Phase I Evaluation of 64Cu-LLP2A for Imaging Multiple Myeloma

The investigators are performing a trial with goals to demonstrate the feasibility of imaging
multiple myeloma (MM) patients with 64Cu-LLP2A-positron emission tomography (PET)/magnetic
resonance (MR). The investigators suggest that 64Cu-LLP2A will allow for an accurate
molecular imaging of MM lesions, which will have an important impact on early stage disease
detection and in the long term on the initiation and choice of therapy in these patients.

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

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

- Not claustrophobic.
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Farrokh Dehdashti, M.D.
Phone: 314-362-1474
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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