First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03665155
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-daratumumab — DRUG
    2 mCi of 89Zr-daratumumab will be administered on day 0.
  • PET/CT scans — DEVICE
    PET/CT images will be obtained on post-administration days 1, 2-4, 5-6, and/or 7-8 following administration of 89Zr-DFO-daratumumab to determine the optimal time point for imaging.
  • Blood draws — OTHER
    Blood and serum samples will be weighed and counted in a scintillation well counter calibrated for 89Zr. Immediately before or after each PET/CT imaging session,

Study Details

The purpose of this study is to test 89Zr-DFO-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.

Key Dates

Start date
Sep 5, 2018
Status verified
Apr 2021
Primary completion
Apr 20, 2020
Completion
Apr 20, 2020

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 89Zr-daratumumab
    Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality. Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients). After pharmacokinetics and radiation dosimetry are determined in phase I, additional patients will be enrolled in phase II.

Primary Outcome Measure

Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants [ Time Frame: up to 19 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Slaon-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Memorial Slaon-Kettering Cancer Center· New York, NY

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