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

Overview

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.

SparkCures ID 915
Trial Phase Phase 1
Enrollment 135 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT03287908

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:

  • Multiple myeloma meeting the following criteria:
    • Pathologically-documented diagnosis of multiple myeloma that has relapsed after or is refractory to established and available therapies with known clinical benefit in relapsed/refractory multiple myeloma
      • Prior lines of therapy 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.
      • 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 6 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

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
Verified Winship Cancer Institute of Emory University -
Verified Medical College of Wisconsin - Froedtert Hospital

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Mayo Clinic Hospital

Phoenix, AZ

Mayo Clinic (Jacksonville)

Jacksonville, FL

Mayo Clinic (Rochester)

Rochester, MN

Arizona
Mayo Clinic Hospital

Phoenix, AZ

Arkansas
Florida
Mayo Clinic (Jacksonville)

Jacksonville, FL

Georgia
Verified Winship Cancer Institute of Emory University -

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Illinois
Minnesota
Mayo Clinic (Rochester)

Rochester, MN

Missouri
New Jersey
Verified John Theurer Cancer Center - Hackensack Meridian Health

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New York
North Carolina
Texas
Wisconsin
Verified Medical College of Wisconsin - Froedtert Hospital

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

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 note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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