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 Dexamethasone Azacitidine AMG 176 Carfilzomib

Eligibility

You can join if…

Open to people ages 18-85

  • (Multiple myeloma subjects) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy
  • (MM subjects only) Measurable disease per the IMWG response criteria
  • (Acute myeloid leukemia subjects) AML as defined by the World Health Organization (WHO) Classification persisting or recurring following one or more treatment courses; EXCEPT acute promyelocytic leukemia.
  • (AML subjects only) More than 5% blasts in bone marrow and Circulating white blood cells (WBCs) < 25,000/ul.
  • Must be willing and able to undergo a core bone marrow biopsy (MM subjects only) and bone marrow aspirate (MM and AML subjects) at screening.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2,
  • (MM subjects only) Satisfactory hematological function without transfusion or growth factor support
  • Life expectancy of > 3 months, in the opinion of the investigator
  • Adequate hepatic function
  • Adequate cardiac function
  • Adequate renal function
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test
  • 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
  • (MM subjects only) Multiple myeloma with IgM subtype
  • (MM subjects only) POEMS syndrome
  • (MM subjects only) Existing plasma cell leukemia
  • (MM subjects only) Waldenstrom's macroglobulinemia
  • (MM subjects only) Amyloidosis
  • (Acute myeloid leukemia Part 4 only) Presence of advanced malignant hepatic tumors with baseline albumin < 3 g/dL
  • Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1)
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II)
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 months
  • Enrollment in other investigational procedures while participating in this study
  • Other exclusion criteria may apply

Locations

  • Research Site
    Sacramento California 95817 United States
  • Research Site
    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