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

What's the purpose of this trial?

At least one dose level of AMG 176 will achieve acceptable safety and tolerability in patients with relapsed or refractory multiple myeloma and patients with relapsed or refractory acute myeloid leukemia

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

INCLUSION CRITERIA:

  • For participants in Japan only: if a participant is younger than 20 years at the time of signing the informed consent form, informed consent must be obtained from both the participant and his/her legal representative
  • (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, and for participants in Japan, determined by the investigator to be not eligible for approved anticancer drug therapy in Japan; 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 enrollment, 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 prior to enrollment
  • Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study will be allowed if approved by Amgen medical monitor
  • Participants with elevated cardiac troponin above the manufacturer's 99th percentile upper reference limit for ADVIA Centaur XP assay at screening performed by the central laboratory
  • Participants with evidence of recent cardiac injury at screening based on creatine kinase-muscle/brain (CK-MB), N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP), and electrocardiogram (ECG)
  • Other exclusion criteria may apply

Additional Trial Information

Phase 1

Enrollment: 119 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Georgia

Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting
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