Multiple Myeloma Clinical Trial

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

Summary

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

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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

175

Study ID:

NCT02675452

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 24 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
University of Colorado
Aurora Colorado, 80045, United States
Northside Hospital
Atlanta Georgia, 30342, United States
University of Chicago Hospital
Chicago Illinois, 60637, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Tom Baker Cancer Centre
Calgary Alberta, T2N 2, Canada
University Health Network-Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Universitätsklinikum der Rheinisch-Westfälischen Technischen Hochschule Aachen
Aachen , 52074, Germany
Universitätsklinikum Bonn
Bonn , 53127, Germany
Universitatsklinikum Ulm
Ulm , 89081, Germany
Universitaetsklinikum Wuerzburg
Würzburg , 97080, Germany
National Hospital Organization Nagoya Medical Center
Nagoya-shi Aichi, 460-0, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Fukuoka, 811-1, Japan
National Hospital Organization Okayama Medical Center
Okayama-shi Okayama, 701-1, Japan
NTT Medical Center Tokyo
Shinagawa-ku Tokyo, 141-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

175

Study ID:

NCT02675452

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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