RECRUITING

A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-08
Study Completion:2026-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04814615

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ≥ 21 years of age
  2. 2. Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
  3. 3. At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
  4. 4. ECOG performance status 0 to 2
  5. 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. 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  2. 2. Life expectancy \< 12 months
  3. 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. 4. History of anaphylactic reaction to humanized or human antibodies.

Contacts and Locations

Study Contact

Gary Ulaner, MD, PhD
CONTACT
949-557-0252
gary.ulaner@hoag.org
Beth Thomsen, CNMT
CONTACT
949-557-0285
beth.thomsen@hoag.org

Principal Investigator

Leila Andreas, MS
STUDY_DIRECTOR
Hoag Memorial Hospital Presbyterian

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Irvine, California, 92614
United States
University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Hoag Memorial Hospital Presbyterian

  • Leila Andreas, MS, STUDY_DIRECTOR, Hoag Memorial Hospital Presbyterian

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-08
Study Completion Date2026-03-15

Study Record Updates

Study Start Date2021-03-08
Study Completion Date2026-03-15

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma
  • 89Zr-daratumumab
  • Dartumumab
  • PET/CT

Additional Relevant MeSH Terms

  • Multiple Myeloma