A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
NCT ID: NCT04467281
Last Updated: 2022-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2020-06-30
2021-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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89Zr-DFO-daratumumab PET/CT
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
89Zr-DFO-daratumumab
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.
PET/CT
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.
Interventions
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89Zr-DFO-daratumumab
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.
PET/CT
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Marius Mayerhoefer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-098
Identifier Type: -
Identifier Source: org_study_id
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