← Back to Search

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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

Select...

My multiple myeloma is CD38 positive.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met