CLINICAL TRIAL / NCT02675452
AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia
- Interventional
- Recruiting
- NCT02675452
Contact Information
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 participants with relapsed or refractory multiple myeloma and participants 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 participants with relapsed or refractory
multiple myeloma and participants with relapsed or refractory acute myeloid leukemia The
study will be conducted in five parts.
Gender
All
Age Group
18 Years to 85 Years
Accepting Healthy Volunteers
No
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 [MM] participants) Pathologically documented, multiple myeloma
relapsed or refractory disease after at least 2 lines of therapy
- (MM participants only) Measurable disease per the International Myeloma Working Group
response criteria
- (Acute myeloid leukemia [AML] participants) AML as defined by the World Health
Organization 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 participants only) More than 5% blasts in bone marrow and Circulating white blood
cells < 25,000/ul.
- Must be willing and able to undergo a core bone marrow biopsy (MM participants only)
and bone marrow aspirate (MM and AML participants) at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2,
- (MM partiicpants 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 participants 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 participants only) MM with Immunoglobulin M subtype
- (MM participants only) Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal
protein, Skin changes syndrome
- (MM participants only) Existing plasma cell leukemia
- (MM participants only) Waldenstrom's macroglobulinemia
- (MM participants only) Amyloidosis
- 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, N-terminal prohormone of brain natriuretic peptide, and
electrocardiogram
- Other exclusion criteria may apply
- (AML Part 3d only) History of QT prolongation, torsades de pointes, ventricular
tachycardia and cardiac arrest
- History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection unless agreed upon with medical monitor.