TheranosticTrials.org

Clinical Trial · NCT03311828

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

Overview

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.

Sponsor

City of Hope Medical Center

Phase

Phase 1

Contacts

Amrita Krishnan, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03311828

Drug / Compound

fludeoxyglucose

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

daratumumab

Isotope(s):
Target(s):
  • CD38
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • Histologically confirmed multiple myeloma (newly diagnosed or relapsed)(Note: multiple myeloma patients with secondary amyloidosis are eligible)
  • Total bilirubin =\< 1.5 x the upper limit of normal (ULN)
  • Calculated creatinine clearance \>= 30 mL/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
  • Absolute neutrophil count (ANC) \>= 1000/mm\^3
  • Platelet count \>= 50/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
  • Karnofsky performance status \> 70%
  • Ability to undergo standard PET imaging; an 18 F FDG PET/CT scan will take place within 3 months of enrollment

Exclusion

  • Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% predicted normal; Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 \< 50%
  • Myocardial infarction within 12 months prior to starting study treatment
  • Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment
  • Squamous cell carcinoma of the skin
  • Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration; the following are exceptions:
  • Basal cell carcinoma of the skin
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
  • Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
  • Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor \[GM-CSF\]); Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
  • Subject has history of primary immunodeficiency
  • Congestive heart failure (New York Heart Association class III or IV)
  • Daratumumab or other anti CD38 antibody treatment within 3 months prior to study enrollment
  • Clinically significant abnormal electrocardiography (ECG) finding at screening
  • Vaccination with live attenuated vaccines within 4 weeks of study agent administration
  • Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
  • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
  • Carcinoma in situ of the cervix
  • Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, CT scan premedication)