A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

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, 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.

Eligibility

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.

Conditions2

Locations2 sites

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