Status:
RECRUITING
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Multiple Myeloma
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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, d...
Detailed Description
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 combinatio...
Eligibility Criteria
Inclusion
- Male or female ≥ 21 years of age
- Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
- At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
- ECOG performance status 0 to 2
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Exclusion
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Life expectancy \< 12 months
- 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.
- History of anaphylactic reaction to humanized or human antibodies.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04814615
Start Date
March 8 2021
End Date
March 15 2026
Last Update
June 27 2023
Active Locations (2)
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1
Hoag Memorial Hospital Presbyterian
Irvine, California, United States, 92614
2
University of Miami
Miami, Florida, United States, 33136