AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma

Overview

This is a Phase 1, first-in-human, multicenter; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia.

SparkCures ID 845
Trial Phase Phase 1
Enrollment 85 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT02675452

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

INCLUSION CRITERIA: -Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy, -Must be willing and able to undergo bone marrow biopsy at screening, -Measurable disease per the IMWG response criteria, -Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2, -Satisfactory hematological function without transfusion or growth factor support, -Subjects should not have received platelet transfusions for at least 1 week prior to screening, -Hemoglobin > 8 g/dL, -Subjects may receive RBC transfusions or receive supportive care), -Other Inclusion Criteria May Apply.

EXCLUSION CRITERIA: -Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease, -Autologous stem cell transplant less than 90 days prior to study day 1, -Multiple myeloma with IgM subtype, -POEMS syndrome, -Existing plasma cell leukemia, -Waldenstrom's macroglobulinemia, -Amyloidosis, -Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to starting treatment, -Topical or inhaled corticosteroids are permitted, -Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1), -Other exclusion Criteria May Apply.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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