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

June 30, 2022 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patient's with positive tumors
Time Frame: 1 year
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

February 26, 2021

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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