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

  • Interventional
  • Not Recruiting
  • NCT02675452
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years to 85 Years

Accepting Healthy Volunteers?
No

INCLUSION CRITERIA:

         - (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

        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

         - (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

At a Glance

National Government IDNCT02675452

IRB#IRB15-1438

Lead SponsorAmgen

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years to 85 Years
Not Recruiting