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A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2020
Shorter than P25 for phase_2 multiple-myeloma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 2, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedJuly 1, 2022
June 1, 2022
8 months
July 2, 2020
June 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patient's with positive tumors
Uptake of FDG PET/CT
1 year
Secondary Outcomes (1)
assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy
1 year
Study Arms (1)
89Zr-DFO-daratumumab PET/CT
EXPERIMENTALPre 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
Interventions
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.
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
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marius Mayerhoefer, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2020
First Posted
July 13, 2020
Study Start
June 30, 2020
Primary Completion
February 26, 2021
Study Completion
February 26, 2021
Last Updated
July 1, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.