A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Study Purpose

Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma in a PET scanner. A phase I study of 89Zr-DFO-daratumumab demonstrated safety and successful visualization of myeloma with 89Zr-DFO-daratumumab. This will be a phase II study of 89Zr-DFO-daratumumab to evaluate potential clinical applications of this novel imaging agent.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female ≥ 21 years of age. 2. Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma. 3. At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment. 4. ECOG performance status 0 to 2. 5. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. Life expectancy < 12 months. 3. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds. 4. History of anaphylactic reaction to humanized or human antibodies.

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.	NCT04814615
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.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hoag Memorial Hospital Presbyterian
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leila Andreas, MS
Principal Investigator Affiliation	Hoag Memorial Hospital Presbyterian
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

Additional Details

This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy. The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.

Arms & Interventions

Arms

Experimental: CD38-positive multiple myeloma

Patients with CD38 positive multiple myeloma with be enrolled. Patients will undergo pretreatment evaluation with standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Patients will then undergo a course of standard of care therapy as defined by a medical oncologist. Following therapy, patients will repeat standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Data analysis will be performed to evaluate 89Zr-daratumumab against standard of care diagnostic tests for the detection and localization of active disease before and after therapy.

Interventions

Drug: - 89Zr-daratumumab PET/CT

CD38-targeting imaging

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.

Hoag Memorial Hospital Presbyterian, Irvine, California

Status

Recruiting

Address

Hoag Memorial Hospital Presbyterian

Irvine, California, 92614

Site Contact

Beth Thomsen

clinicaltrials@hoag.org

949-557-0252

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Michelle D. Armogan

mda182@med.miami.edu

305-243-7479

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