A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Description

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.

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

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.

A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications

A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Irvine

Hoag Memorial Hospital Presbyterian, Irvine, California, United States, 92614

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoag Memorial Hospital Presbyterian,

Leila Andreas, MS, STUDY_DIRECTOR, Hoag Memorial Hospital Presbyterian

Study Record Dates

2026-03-15