Clinical Trial Summary

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Phase

Phase 2

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Funding Agency/Sponsor

Externally Peer-Reviewed

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Disease

Myeloma

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Enrollment 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.

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