Summary

for people ages 18-85 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Relapsed or Refractory Multiple Myeloma Relapsed or Refractory Acute Myeloid Leukemia Leukemia Leukemia, Myeloid Multiple Myeloma Neoplasms, Plasma Cell Leukemia, Myeloid, Acute AMG 176

Eligibility

You can join if…

Open to people ages 18-85

-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.

You CAN'T join if...

-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.

Locations

  • Research Site accepting new patients
    Sacramento California 95817 United States
  • Research Site accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
Sign up for this study
ID
NCT02675452
Phase
Phase 1
Study Type
Interventional
Last Updated