Using a new imaging technique to detect multiple myeloma
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
PHASE2 · Hoag Memorial Hospital Presbyterian · NCT04814615
This study is testing a new imaging method to see if it can better detect multiple myeloma in patients who are about to start standard treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Hoag Memorial Hospital Presbyterian (other) |
| Drugs / interventions | daratumumab |
| Locations | 2 sites (Irvine, California and 1 other locations) |
| Trial ID | NCT04814615 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the clinical value of a novel immunoPET tracer, 89Zr-DFO-daratumumab, designed to visualize multiple myeloma cells by targeting CD38. The study will enroll 60 patients with confirmed multiple myeloma who are scheduled to receive standard daratumumab therapy. Participants will undergo both standard imaging and the new immunoPET imaging before and after treatment to assess the effectiveness of the new method in measuring disease burden and predicting treatment response. The goal is to determine if this innovative imaging technique provides additional insights compared to current standard methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with confirmed CD38-positive multiple myeloma and at least one detectable tumor lesion.
Not a fit: Patients with a life expectancy of less than 12 months or those unable to undergo PET/CT scanning due to weight restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of myeloma disease assessment and improve treatment planning for patients.
How similar studies have performed: Previous studies have shown promising results with similar imaging approaches, but this specific application of immunoPET is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Irvine, California and 1 other locations
- Hoag Memorial Hospital Presbyterian — Irvine, California, United States (RECRUITING)
- University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Gary Ulaner, MD, PhD
- Email: gary.ulaner@hoag.org
- Phone: 949-557-0252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, 89Zr-daratumumab, Dartumumab, PET/CT