A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

NCT ID: NCT04814615

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2026-03-15

Brief 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.

Detailed Description

This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy.

The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

89Zr-daratumumab PET/CT

Intervention Type: DRUG

CD38-targeting imaging

Interventions

89Zr-daratumumab PET/CT

CD38-targeting imaging

Intervention Type: DRUG

Other Intervention Names

CD38-targeted imaging

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role: lead

Responsible Party

Gary Ulaner

Director Molecular Imaging and Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leila Andreas, MS

Role: STUDY_DIRECTOR

Hoag Memorial Hospital Presbyterian

Locations

Hoag Memorial Hospital Presbyterian

Irvine, California, United States

Site Status: RECRUITING

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gary Ulaner, MD, PhD

Role: CONTACT

gary.ulaner@hoag.org

949-557-0252

Beth Thomsen, CNMT

Role: CONTACT

beth.thomsen@hoag.org

949-557-0285

Facility Contacts

Beth Thomsen

Role: primary

clinicaltrials@hoag.org

Michelle D. Armogan

Role: primary

mda182@med.miami.edu

305-243-7479

Other Identifiers

177-20-CA

Identifier Type: -

Identifier Source: org_study_id