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64Cu-LLP2A for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MOMultiple Myeloma64Cu-LLP2A - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Up to 30 hours after imaging

Day 4
Feasibility of imaging MM patients with 64Cu-LLP2A-PET/MR as measured by the number of participants who experience an adverse event related to 64Cu-LLP2A
Hour 30
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
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
Feasibility of imaging MM patients with 64Cu-LLP2A-PET/MR as measured by the optimal image time after injection of 64Cu-LLP2A

Trial Safety

Safety Progress

1 of 3

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1
[18F]FLT-PET/CT
1
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Trial Design

2 Treatment Groups

Cohort 2: Quantitative 64Cu-LLP2A Imaging
1 of 2
Cohort 1: Pilot 64Cu-LLP2A Imaging
1 of 2

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: 64Cu-LLP2A · No Placebo Group · Phase < 1

Cohort 2: Quantitative 64Cu-LLP2A ImagingExperimental Group · 7 Interventions: PET/CT, Blood samples for serum stability, 64Cu-LLP2A, PET/MR, Tumor biopsy, Electrocardiogram, Blood samples for metabolite analysis · Intervention Types: Device, Procedure, Drug, Device, Procedure, Procedure, Procedure
Cohort 1: Pilot 64Cu-LLP2A ImagingExperimental Group · 7 Interventions: Urine sample, PET/CT, Blood samples for serum stability, 64Cu-LLP2A, PET/MR, Electrocardiogram, Blood samples for metabolite analysis · Intervention Types: Procedure, Device, Procedure, Drug, Device, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urine sample
2011
N/A
~3300
PET/CT
2020
Completed Phase 3
~1060
PET/MR
2018
Completed Phase 3
~100
Tumor biopsy
2014
Completed Phase 2
~240
Electrocardiogram
2014
Completed Phase 2
~3040

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 hours after imaging

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,283,972 Total Patients Enrolled
27 Trials studying Multiple Myeloma
1,123 Patients Enrolled for Multiple Myeloma
Farrokh Dehdashti, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
214 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate in the study if you have myeloma and are planning to start a new treatment or resume a previous treatment.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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