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
Tags
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

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health

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Northside Hospital

Atlanta, GA

California
Georgia
Northside Hospital

Atlanta, GA

Illinois
Massachusetts
New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

Texas
Utah
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

There are no resources, links or videos to display for this clinical trial.

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