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

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    127
  • sponsor
    Amgen
Updated on 14 June 2021

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

Description

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.

Details
Condition Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Acute Myeloid Leukemia
Treatment Itraconazole, Azacitidine, AMG 176
Clinical Study IdentifierNCT02675452
SponsorAmgen
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

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
(Acute myeloid leukemia Part 3d only) History of QT prolongation, torsades de pointes, ventricular tachycardia and cardiac arrest
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