AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 85
Updated:3/30/2019
Start Date:June 13, 2016
End Date:November 7, 2021
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

At least one dose level of AMG 176 will achieve acceptable safety and tolerability in
subjects with relapsed or refractory multiple myeloma and subjects with relapsed or
refractory acute myeloid leukemia

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 The study
will be conducted in four parts.

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.
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St Leonards, New South Wales 2065
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