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ImmunoPET Imaging for Multiple Myeloma

Phase 2
Recruiting
Research Sponsored by Hoag Memorial Hospital Presbyterian
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
ECOG performance status 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new way to image myeloma in order to improve treatment planning and evaluation. So far the new imaging agent is safe and successful in visualizing myeloma.

Who is the study for?
This trial is for adults over 21 with confirmed CD38-positive multiple myeloma, who have at least one tumor visible on recent scans and can follow the study's procedures. It's not for pregnant or breastfeeding individuals, those not using birth control, patients expected to live less than a year, or anyone too heavy for PET/CT scanners.Check my eligibility
What is being tested?
The trial tests an imaging agent called 89Zr-DFO-daratumumab in a PET scanner to visualize myeloma cells. This phase II study aims to assess how well it works and its potential clinical uses after showing safety and effectiveness in an earlier phase I trial.See study design
What are the potential side effects?
While specific side effects are not listed here, similar diagnostic agents may cause allergic reactions or discomfort at the injection site. The use of PET/CT involves exposure to radiation which carries a risk of cancer over the long term.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma is CD38 positive.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging
89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging
Prediction of response to therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD38-positive multiple myelomaExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hoag Memorial Hospital PresbyterianLead Sponsor
34 Previous Clinical Trials
14,635 Total Patients Enrolled
2 Trials studying Multiple Myeloma
Deborah Fridman, PsyD, RNStudy DirectorHoag Memorial Hospital Presbyterian
1 Previous Clinical Trials
184 Total Patients Enrolled
Leila Andreas, MSStudy DirectorHoag Memorial Hospital Presbyterian

Media Library

89Zr-daratumumab PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04814615 — Phase 2
Multiple Myeloma Research Study Groups: CD38-positive multiple myeloma
Multiple Myeloma Clinical Trial 2023: 89Zr-daratumumab PET/CT Highlights & Side Effects. Trial Name: NCT04814615 — Phase 2
89Zr-daratumumab PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814615 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does 89Zr-daratumumab PET/CT help doctors treat their patients?

"89Zr-daratumumab PET/CT is a standard treatment for biological response modifiers. Additionally, this method can be used to help patients with relapsed or refractory multiple myeloma, cell transplants, and other conditions."

Answered by AI

Are there any current vacancies for this trial?

"That is accurate. The clinicaltrials.gov website has information indicating that this study is recruiting patients. This research was originally posted on March 8th, 2021 and updated most recently on August 1st, 2022. The trial needs to recruit 60 individuals from 1 location."

Answered by AI

Are there other ongoing research projects that use 89Zr-daratumumab PET/CT?

"142 different clinical trials involving 89Zr-daratumumab PET/CT are currently underway. Most of these studies are in Phase 3 with 26 total trials. The majority of these medical investigations are taking place in Harrison, New york but there 5582 locations running some form of trial for this procedure."

Answered by AI

What is the uppermost limit of people who can join this trial?

"Yes, as indicated by the most recent update on clinicaltrials.gov, this study is currently seeking volunteers. The trial was originally posted on March 8th, 2021 and is hoping to enroll 60 individuals at a single site."

Answered by AI

Does 89Zr-daratumumab PET/CT have any negative side effects?

"While 89Zr-daratumumab PET/CT has some evidence backing its safety, it is still unproven in terms of efficacy. Therefore, it received a score of 2."

Answered by AI
~22 spots leftby Jan 2026