A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma

Date de début de l'étude : 20 novembre 2015

Inclusion Criteria: \- Pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalidomide). * Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines). * Measurable disease per the International Myeloma Working Group (IMWG) response criteria * Hematological function, as follows, without transfusion support: * Absolute neutrophil count ≥ 1.0 X 10\^9/L, * Platelet count ≥ 75 X 10\^9/L (in patients with \< 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 X 10\^9/L (in patients with ≥ 50% of bone marrow nucleated cells were plasma cells) without transfusion or growth factor support * Hemoglobin \> 8 g/dL (\> 80 g/L) * Adequate renal and hepatic function * Left ventricular ejection fraction (LVEF) \> 50% Exclusion Criteria: * Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study * Autologous stem cell transplant less than 90 days prior to study day 1 * Multiple myeloma with IgM subtype * POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis * Glucocorticoid therapy (prednisone \> 30 mg/day or equivalent) within 7 days prior to study day * Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II) * A baseline ECG QTcF \> 470 msec * Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1