A Phase 1/2 Study of AMG 701 in Subjects With Multiple Myeloma

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

A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 in Subjects With Multiple Myeloma (ParadigMM-1B)

The primary purpose of the phase 1 part of the study is to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, RP2D) and to confirm the safety and tolerability of the RP2D. The dose escalation part of the study will be conducted at multiple sites and test increasing doses and dosing schedules of AMG 701. This will be followed by Phase 1b dose confirmation and Phase 2 dose expansion parts to gain further efficacy and safety experience with 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 = 3 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 combination in the same line or separate lines 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:

         - Known extramedullary relapse 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

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

         - Waldenstrom's macroglobulinemia

         - Prior amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met)

         - 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 any drug or construct that targets BCMA on tumor cells (eg, other bispecific antibody constructs, antibody drug conjugates, or CAR-T cells), other than Group C where prior treatment with GSK2857916 (belantamab mafodotin) is required.

At a Glance

National Government IDNCT03287908

IRB#IRB17-1230

Lead SponsorAmgen

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting