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A Phase 1/2a Open-label, Dose-Escalation Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Patients with Relapsed/Refractory Multiple Myeloma

Clinical Trial Details

This is a phase 1/2a study designed to determine the safety and tolerability of TAK-079 monotherapy in women and men age 18 and older with relapsed or refractory multiple myeloma. TAK-079 is a fully human antibody that targets CD38+ leukocytes. TAK-079 treatment results in a rapid depletion of CD38. A number of hematologic tumors express CD38, including multiple myeloma (MM), acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma.

Subjects will receive TAK-079 via subcutaneous administration in each 28-day cycle of treatment, administered as once weekly for 8 weeks (8 doses), once every 2 weeks for 16 weeks (8 doses), and once every 4 weeks thereafter until disease progression. 

Key Eligibility: 

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
  • Has received previous myeloma-specific therapy
  • In the Combination Cohort (TAK-079-PomDex) only, must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator and the Pomalyst product information
  • Documentation of RRMM as defined by the International Myeloma Working Group (IMWG) criteria
  • Participants with MM, measurable disease

Exclusion Criteria

  • Sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade greater than or equal to 3
  • Have received allogeneic stem cell transplant
  • Have received anti-CD38 antibody therapy and do not fulfill a 180-day washout period before receiving TAK-079.
  • Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade greater than or equal to 1 or baseline, excluding alopecia
  • Clinical signs of central nervous system (CNS) involvement of MM
  • Active chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active HIV, or cytomegalovirus (CMV) infection
  • POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or IgM myeloma
  • Positive Coombs tests at screening
  • For participants in the Combination Cohort (TAK-079-PomDex) only: participant has previously received pomalidomide or has hypersensitivity to thalidomide or lenalidomide

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1801018901

ClinicalTrials.gov:

NCT03439280

Status

Open to Enrollment

Age Group

Adult

Sponsor