AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma

Overview

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.

SparkCures ID 845
Trial Phase Phase 1
Enrollment 119 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT02675452

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:

  • 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more


Northside Hospital

Atlanta, GA

California
Georgia
Northside Hospital

Atlanta, GA

Illinois
Massachusetts
New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

Texas
Utah
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

There are no resources, links or videos to display for this clinical trial.

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