A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma

Study Overview
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Brief Summary
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The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with PET/CT scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. We also want to see if 89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if they can better locate any leftover disease following treatment compared to the standard imaging methods.

Official Title
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A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: 89Zr-DFO-daratumumab
* Diagnostic Test: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 years Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment ECOG performance status 0 to 2 Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf). Exclusion Criteria: Life expectancy < 12 months Pregnancy or lactation Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds. History of anaphylactic reaction to humanized or human antibodies. Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This will be a phase II clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 89Zr-DFO-daratumumab PET/CT<br>Pre treatment evaluation: 1) Standard of Care (SoC) labs, imaging, blind bone marrow biopsy. 2) Baseline research 89 Zr DFO daratumumab PET/CT 3) Possible biopsy of 89 Zr DFO daratumumab avid lesion Treatment: Daratumumab containing combination therapy (up to 12 cycles, 4 weeks/cycle). SoC labs, imaging, and blind bone marrow biopsies until complete response (CR) is suspected or 12 cycles are completed. Post treatment evaluation:1) SoC labs, imaging, and blind bone marrow biopsy 2) SoC minimal residual disease (MRD) analysis by next generation sequencing 3) Follow up research 89 Zr DFO daratumumab PET/CT 4) Possible biopsy of 89 Zr DFO daratumumab avid lesion | Drug: 89Zr-DFO-daratumumab<br>* Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.<br>Diagnostic Test: PET/CT<br>* Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient's with positive tumors | Uptake of FDG PET/CT | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy | The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD38-Targeted ImmunoPET, 20-098