A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma

Overview

This is a first in human phase 1 multicenter open label study to evaluate the safety and tolerability of AMG 224 in subjects with relapsed or refractory multiple myeloma.

The study will be conducted in 2 parts. Part 1 is the dose-exploration and part 2 is the dose-expansion. Study medication will be administered once every 3 weeks by IV.

SparkCures ID 852
Trial Phase Phase 1
Enrollment 50 Patients
Treatments
  • AMG 224
Trial Sponsors
  • Amgen
NCT Identifier

NCT02561962

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 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 IMWG response criteria
  • Hematological function, as follows, without transfusion support:
  • Absolute neutrophil count ≥ 1.0 X 109/L,
  • Platelet count ≥ 75 X 109/L (in patients with < 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 X 109/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
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1
  • Multiple myeloma with IgM subtype
  • Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to study day
  • Autologous stem cell transplant less than 90 days prior to study day 1
  • POEM syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis
  • 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

US Trial Locations

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

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