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.
5. Previous treatment with daratumumab. Previous treatment with other myeloma therapies
will be allowed.

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