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

  • Interventional
  • Recruiting
  • NCT03287908
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03287908

IRB#IRB17-1230

Lead SponsorAmgen

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting