A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

• Status: Recruiting
• Trial end date: 2025-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoag Memorial Hospital Presbyterian
• Treatments: Daratumumab

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.

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