Recruiting
Phase 2

ImmunoPET

Sponsor:

Hoag Memorial Hospital Presbyterian

Code:

NCT04814615

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

89Zr-daratumumab PET/CT

Study Details

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

Study ID

NCT04814615

Start date

Mar 8, 2021

Status verified date

Jun, 2023

Completion date

Mar 15, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

89Zr-daratumumab PET/CT

CD38-targeting imaging

Primary outcome measure

  • 89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging [ Time Frame: up to 3 years ]
  • 89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging [ Time Frame: up to 3 years ]
  • Prediction of response to therapy [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

Gary Ulaner, MD, PhD

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

Beth Thomsen, CNMT

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

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Irvine, California, United States, 92614

Contacts

Beth Thomsen

clinicaltrials@hoag.org

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Michelle D. Armogan

305-243-7479mda182@med.miami.edu

Principal Investigator:

C. Ola Landgren, MD, PhD.

More Information

Sponsor

Hoag Memorial Hospital Presbyterian

Last update posted

Jun 27, 2023

Last verified

Jun, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hoag Memorial Hospital Presbyterian on 2023-06-27.