A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Part of paid clinical trials in Irvine, California.

Sponsor
Hoag Memorial Hospital Presbyterian
Study ID
NCT04814615
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 8, 2021
Status verified
Jun 2023
Primary completion
Jan 31, 2026
Completion
Mar 15, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging [ Time Frame: up to 3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianIrvineCalifornia92614
Beth Thomsen
[email protected]
University of MiamiMiamiFlorida33136
Michelle D. Armogan
[email protected]
305-243-7479
C. Ola Landgren, MD, PhD. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Hoag Memorial Hospital Presbyterian· Irvine, CAUniversity of Miami· Miami, FL

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