A Phase 1 Study of AMG 701 in Subjects With Multiple Myeloma



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:November 13, 2017
End Date:March 21, 2025
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 in Subjects With Multiple Myeloma

The purpose of this First-in-Human Phase 1 study is to determine during the escalation part
if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose
expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects
with relapsed / refractory multiple myeloma. The study will be conducted in multiple sites
and test increasing doses of AMG 701. The safety of subjects will be monitored by intensive
assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.


Inclusion Criteria:

- Multiple myeloma meeting the following criteria:

- Pathologically-documented diagnosis of multiple myeloma that is relapsed or is
refractory as defined by the following:

- Relapsed after > or = 2 lines of prior therapy that must include a
proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and, where
approved and available, a CD38-directed cytolytic antibody in any order
during the course of treatment OR refractory to PI, IMiD, and CD38- directed
cytolytic antibody,

- Subjects who could not tolerate a PI, IMiDs, or a CD38-directed cytolytic
antibody are eligible to enroll in the study.

- Measurable disease as per IMWG response criteria

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

Exclusion Criteria:

- Extramedullary disease in the absence of any measurable medullary involvement

- Known central nervous system involvement by multiple myeloma

- Autologous stem cell transplantation less than 90 days prior to study day 1

- Multiple myeloma with IgM subtype

- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes)

- Known history of primary plasma cell leukemia or evidence of primary or secondary
plasma cell leukemia at the time of screening

- Waldenstrom's macroglobulinemia

- Amyloidosis

- Treatment with systemic immune modulators including, but not limited to, nontopical
systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent),
cyclosporine, and tacrolimus within 2 weeks before study day 1

- Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2
weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks
prior to study day 1 as well as systemic radiation therapy within 28 days prior to
study day 1 or focal radiotherapy within 14 days prior to study day 1.

- Prior treatment with a drug that targets BCMA on tumor cells or any other bi specific
antibody construct or chimeric antigen receptor T cell (CAR-T) infusion for the
treatment of multiple myeloma
We found this trial at
13
sites
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Hackensack, NJ
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Atlanta, GA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chicago, IL
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Houston, TX
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Jacksonville, FL
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Melbourne,
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Milwaukee, WI
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New York, NY
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Phoenix, AZ
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Rochester, MN
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Saint Louis, MO
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