Copper 64Cu-DOTA-Daratumumab Positron Emission Tomography in Diagnosing Patients With Relapsed Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03311828
Phase
PHASE1
Status
Completed

Conditions

  • Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma
  • Secondary Amyloidosis

Eligibility Criteria

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

Interventions

  • Daratumumab — BIOLOGICAL
    Given IV
  • Imaging Agent — DRUG
    Given Copper 64Cu-DOTA-daratumumab IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This pilot phase I clinical trial studies how well copper 64Cu-DOTA-daratumumab positron emission tomography works in diagnosing patients with multiple myeloma that has come back. Diagnostic procedures, such as copper 64Cu-DOTA-daratumumab positron emission tomography, may help evaluate the extent of multiple myeloma in patients prior to the initiation of treatment and ultimately monitor disease status/response during and post treatment.

Key Dates

Start date
Feb 21, 2018
Status verified
Mar 2024
Primary completion
Jan 22, 2020
Completion
Jun 5, 2023

Study Design

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

Arms

  • Experimental: Diagnostic (Copper 64Cu-DOTA-daratumumab, PET)
    Patients receive daratumumab IV over 10-45 minutes, and within 6 hours, patients receive copper 64Cu-DOTA-daratumumab IV on day 0. Patients undergo PET on days 1 and 2.

Primary Outcome Measure

Incidence of adverse event [ Time Frame: Up to 7 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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