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

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? 89Zr-daratumumab PET/CT
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Male or female ≥ 21 years of age

• Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma

• At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment

• ECOG performance status 0 to 2

• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Locations
United States
California
Hoag Memorial Hospital Presbyterian
RECRUITING
Irvine
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Gary Ulaner, MD, PhD
gary.ulaner@hoag.org
949-557-0252
Backup
Beth Thomsen, CNMT
beth.thomsen@hoag.org
949-557-0285
Time Frame
Start Date: 2021-03-08
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 60
Treatments
Experimental: CD38-positive multiple myeloma
Patients with CD38 positive multiple myeloma with be enrolled. Patients will undergo pretreatment evaluation with standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Patients will then undergo a course of standard of care therapy as defined by a medical oncologist. Following therapy, patients will repeat standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Data analysis will be performed to evaluate 89Zr-daratumumab against standard of care diagnostic tests for the detection and localization of active disease before and after therapy.
Related Therapeutic Areas
Sponsors
Leads: Hoag Memorial Hospital Presbyterian

This content was sourced from clinicaltrials.gov