Study Evaluating AMG 424 in Subjects With Multiple Myeloma

Overview

Part 1 of the study is dose evaluating and aimed at assessing the safety and tolerability of AMG 424 while determining the maximum tolerated dose (MTD) and/or biologically active dose in subjects with relapsed/ refractory multiple myeloma. Part 2 of the study will further evaluate safety and tolerability of the AMG 424 MTD dose determined in Part 1, in groups of subjects with relapsed/ refractory multiple myeloma that include those with high or low cytogenetic risk.

SparkCures ID 966
Trial Phase Phase 1
Enrollment 120 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT03445663

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 at least two prior lines of therapy that must include a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and, where approved and available, anti-CD38 therapy in any order OR that is refractory to PI, IMiD, and anti-CD38 therapy.
    • Subjects who could not tolerate a PI, IMiDs, or a CD38-directed therapeutic antibody due to unacceptable toxicities 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:

  • Known central nervous system involvement by multiple myeloma
  • Previously received allogeneic stem cell transplant and one or more of the following:
    • received the transplant < 6 months prior to study Day 1
    • received immunosuppressive therapy < 3 months prior to study Day 1
    • any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
    • any systemic therapy against GvHD < 2 weeks prior to study Day 1
  • 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
  • Dexamethasone at cumulative doses of greater than 160 mg or equivalent <3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
  • Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study Day 1
  • Treatment with a therapeutic antibody targeting CD38 < 12 weeks prior to study Day 1
  • Systemic radiation therapy or major surgery < 28 days prior to study Day 1 as well as focal radiotherapy < 14 days prior to study Day 1.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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