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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04467281

Collaborator

(none)

Enrollment

Arm

7.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: 89Zr-DFO-daratumumab Diagnostic Test: PET/CT	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This will be a phase II clinical trial.This will be a phase II clinical trial.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 30, 2020

Actual Primary Completion Date :

Feb 26, 2021

Actual Study Completion Date :

Feb 26, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

number of patient's with positive tumors [1 year]
Uptake of FDG PET/CT

Secondary Outcome Measures

assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Marius Mayerhoefer, MD, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT04467281

Other Study ID Numbers:

20-098

First Posted:

Jul 13, 2020

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

CD38-Targeted ImmunoPET

20-098

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Daratumumab

Study Results

No Results Posted as of Jul 1, 2022