A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04814615
• Other study ID #: 177-20-CA
• Status: Recruiting
• Phase: Phase 2
• Start date: March 8, 2021
• Est. completion date: March 15, 2026

Study information

• Verified date: June 2023
• Source: Hoag Memorial Hospital Presbyterian
• Contact: Gary Ulaner, MD, PhD
• Phone: 949-557-0252
• Email: gary.ulaner[@]hoag.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 15, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 89Zr-daratumumab PET/CT
CD38-targeting imaging

Locations

Country	Name	City	State
United States	Hoag Memorial Hospital Presbyterian	Irvine	California
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Prediction of response to therapy	Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy	up to 3 years