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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 belowSelect...
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.
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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
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have at least one visible tumor on a recent CT, MRI, or PET scan.You are not expected to live for another year.My multiple myeloma is CD38 positive.You had a severe allergic reaction to humanized or human antibodies in the past.You weigh more than 450 pounds and may not fit in the PET/CT scanner.I can take care of myself and am up and about more than half of my waking hours.I am 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: CD38-positive multiple myeloma
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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