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64Cu-LLP2A Imaging for Multiple Myeloma

Phase < 1
Recruiting
Led By Farrokh Dehdashti, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients 18 years of age or older with clinically or pathologically defined MM in accordance with International Myeloma Working Group or as stated in office note / clinical assessment from treating physician.
All types of active myeloma are eligible including both newly diagnosed and previously treated provided plans are to start a new treatment or restart a prior treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 hours after imaging
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new way to image multiple myeloma lesions using PET/MR. The hope is that this will help with early detection and choosing the best treatment.

Who is the study for?
This trial is for adults over 18 with multiple myeloma, including those newly diagnosed or previously treated who are starting new therapy. Participants must be able to consent and have no metal implants that interfere with PET/MR imaging. They should not be pregnant/nursing and have a GFR of at least 60 mg/mL/1.73 m^2 if receiving MRI contrast.Check my eligibility
What is being tested?
The trial tests the use of a radioactive tracer called 64Cu-LLP2A in combination with PET/MR imaging to detect multiple myeloma lesions accurately. It aims to improve early disease detection and influence treatment choices by providing better molecular images of cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to the injection of the tracer (like discomfort or bruising), allergic reactions, exposure to radiation from imaging, and any risks associated with biopsy procedures if performed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and have been diagnosed with multiple myeloma.
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I have active myeloma and am starting or restarting treatment.
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My kidney function is good enough for MRI contrast.
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I am not pregnant or nursing, and cannot become pregnant or am not currently pregnant.
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I am over 18, healthy, and do not have blood disorders like anemia or leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 hours after imaging
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 hours after imaging for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of imaging MM patients with 64Cu-LLP2A-PET/MR as measured by average organ activity concentration of 64Cu-LLP2A
Feasibility of imaging MM patients with 64Cu-LLP2A-PET/MR as measured by image quality of 64Cu-LLP2A-PET/MR images
Feasibility of imaging MM patients with 64Cu-LLP2A-PET/MR as measured by lesion detection of 64Cu-LLP2A-PET/MR images
+2 more
Secondary outcome measures
Comparision of tumor burden (SUVmax) of 64Cu-LLP2A to clinical measurement of tumor burden as measured by the plasma cell fraction within the bone marrow
Comparison of tumor burden (SUVmax) of 64Cu-LLP2A to clinical stage
Comparison of tumor burden (SUVmax) of 64Cu-LLP2A to clinical tumor measurement of tumor burden as measured by M-protein of myeloma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Quantitative 64Cu-LLP2A ImagingExperimental Treatment7 Interventions
20 patients with MM will be recruited Subjects who enter on study in Cohort 2 will undergo a 60-min dynamic imaging over the known site of disease (OR pelvis and lower lumbar spine, if no site of disease is known). Following a simple DIXON MRI or low dose CT scan for attenuation correction, subjects will be injected with a dose of up to11 mCi of 64Cu-LLP2A and a list mode dynamic imaging acquisition will begin for a total of 60 mins. Following the dynamic study, or at the optimal time point determined from cohort 1 imaging, after a simple DIXON or low dose CT scan for body (top of the head to below the knees) attenuation correction, emission scans (2-5 min per bed position) will be performed
Group II: Cohort 1: Pilot 64Cu-LLP2A ImagingExperimental Treatment7 Interventions
16 adult individuals (6-8 patients with known MM; 6-10 healthy volunteers) All subjects who enter the study in Cohort 1 will be injected with up to 11 mCi of 64Cu-LLP2A and will undergo body imaging at least twice within 0-30 hrs following administration of 64Cu-LLP2A to study tracer biodistribution and calculate human dosimetry 6 subjects will also undergo dynamic study for 60 mins immediately after administration of 64Cu-LLP2A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urine sample
2011
N/A
~3330
PET/CT
2022
Completed Phase 3
~1240
PET/MR
2018
Completed Phase 3
~100
Tumor biopsy
2014
Completed Phase 2
~240
Electrocardiogram
2014
Completed Phase 2
~3060

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,921 Previous Clinical Trials
2,293,881 Total Patients Enrolled
30 Trials studying Multiple Myeloma
1,191 Patients Enrolled for Multiple Myeloma
Farrokh Dehdashti, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
205 Total Patients Enrolled

Media Library

64Cu-LLP2A Clinical Trial Eligibility Overview. Trial Name: NCT03804424 — Phase < 1
Multiple Myeloma Research Study Groups: Cohort 2: Quantitative 64Cu-LLP2A Imaging, Cohort 1: Pilot 64Cu-LLP2A Imaging
Multiple Myeloma Clinical Trial 2023: 64Cu-LLP2A Highlights & Side Effects. Trial Name: NCT03804424 — Phase < 1
64Cu-LLP2A 2023 Treatment Timeline for Medical Study. Trial Name: NCT03804424 — Phase < 1

Frequently Asked Questions

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

How many participants are enrolled in this trial at maximum capacity?

"Affirmative, clinicaltrials.gov data suggests that this research trial is currently recruiting volunteers. Initially posted on November 20th 2018, the project was last updated on July 27th 2022 and seeks 36 participants from a single medical center."

Answered by AI

Is recruitment to this trial still open?

"Affirmative. Per the clinicaltrials.gov website, this trial is currently recruiting participants - it was first posted on November 20th 2018 and recently updated on July 27th 2022. For now, 36 patients are needed from 1 location for further study."

Answered by AI
~4 spots leftby Nov 2024