64Cu-LLP2A for Imaging Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03804424
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Farrokh Dehdashti, M.D.
Principal Investigator Affiliation Washington University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Cohort 1: Pilot 64Cu-LLP2A Imaging

12 adult individuals (6 patients with known MM; 6 healthy volunteers) All subjects who enter the study in Cohort 1 will be injected with 11 mCi (RANGE 8.8-13.2 mCi) of 64Cu-LLP2A and undergo body imaging twice within 0-30 hrs following administration of 64Cu-LLP2A to study tracer biodistribution and calculate human dosimetry Body imaging will be performed approximately at the following time points: Immediately after 64Cu-LLP2A administration (2 subjects 1 healthy volunteer and 1 subject with MM) 1 to 3 hours after 64Cu-LLP2A administration (4 subjects) 3 to 8 hours after 64Cu-LLP2A administration (4 subjects) 18 to 30 hours after 64Cu-LLP2A administration (2 subjects: 1 healthy volunteer and 1 subject with MM) 10 of the subjects will also undergo dynamic study for 60 mins immediately after administration of 64Cu-LLP2A.

Experimental: Cohort 2: Quantitative 64Cu-LLP2A Imaging

20 patients with MM will be recruited Subjects who enter on study in Cohort 2 will undergo a 60-min dynamic image over the known site of disease (OR pelvis and lower lumbar spine, if no site of disease is known). Following a simple DIXON MRI scan for attenuation correction, subjects will be injected with a dose of 11 mCi of 64Cu-LLP2A (RANGE 8.8 - 13.2 mCi) and a list mode dynamic imaging acquisition will begin for a total of 60 mins. Following the dynamic study, or at the optimal time point determined from cohort 1 imaging, after a simple DIXON scan for body (top of the head to below the knees) attenuation correction, emission scans (2-5 min per bed position) will be performed

Interventions

Drug: - 64Cu-LLP2A

-64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)

Device: - PET/MR

-All PET imaging will be performed with a Siemens mMR PET/MR scanner

Procedure: - Blood samples for serum stability

-3 venous samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (2 mL each) will be obtained at the following time points: Cohort 1: prior to injection, at completion of dynamic scanning in those who undergo dynamic imaging and at completion of one of the body imaging time points. In those who do not undergo dynamic imaging, prior to injection, and after completing body imaging at 2 of the 3 time points. Cohort 2: subjects will have samples drawn prior to injection, at completion of dynamic scanning, and at completion of body imaging.

Procedure: - Blood samples for metabolite analysis

-Typically, 2 blood samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (preferably 1 within the first 5 min and 1 at the completion of the first hour of imaging) will be obtained.

Procedure: - Urine sample

-Cohort 1 only

Procedure: - Tumor biopsy

-Cohort 2 only and only if there hasn't been a recent biopsy of disease

Procedure: - Electrocardiogram

-A standard 12-lead ECG will be obtained on all subjects at baseline (within 30 mins prior to injection of 64Cu-LLP2A), and at least 60 minutes post injection or prior to study discharge

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Farrokh Dehdashti, M.D.

dehdashtif@wustl.edu

314-362-1474