A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

NCT04814615 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 177-20-CA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging

  89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma prior to therapy

  up to 3 years

• 89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging

  89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma following therapy

  up to 3 years

• Prediction of response to therapy

  Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy

  up to 3 years

Study Arms (1)

CD38-positive multiple myeloma

EXPERIMENTAL

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.

Drug: 89Zr-daratumumab PET/CT

Interventions

89Zr-daratumumab PET/CT DRUG

CD38-targeting imaging

Also known as: CD38-targeted imaging

CD38-positive multiple myeloma

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Life expectancy \< 12 months
• 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.
• History of anaphylactic reaction to humanized or human antibodies.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (2)

Hoag Memorial Hospital Presbyterian

Irvine, California, 92614, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Leila Andreas, MS

  Hoag Memorial Hospital Presbyterian

  STUDY DIRECTOR

Central Study Contacts

Gary Ulaner, MD, PhD

CONTACT

949-557-0252; gary.ulaner@hoag.org

Beth Thomsen, CNMT

CONTACT

949-557-0285; beth.thomsen@hoag.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Molecular Imaging and Therapy

Model Details: Individual dose of 89Zr-DFO-daratumumab will be requested from Memorial Sloan Kettering Cancer Center and received at the Hoag Family Cancer Institute radiopharmacy for each individual 89Zr-DFO-daratumumab administration.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 8, 2021
• Primary Completion: January 31, 2026
• Study Completion: March 15, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)