Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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)

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AMG 701
Comparison of different dosages of drug
  • Drug: AMG 701
    Patients will receive IV infusions of AMG 701

Recruiting Locations

Research Site
Phoenix, Arizona 85054

Research Site
Little Rock, Arkansas 72205

Research Site
Jacksonville, Florida 32224

Research Site
Atlanta, Georgia 30322

Research Site
Chicago, Illinois 60637

Research Site
Rochester, Minnesota 55905

Research Site
Saint Louis, Missouri 63110

Research Site
New York, New York 10029

Research Site
New York, New York 10032

Research Site
New York, New York 10065

Research Site
Charlotte, North Carolina 28204

Research Site
Houston, Texas 77030

Research Site
Salt Lake City, Utah 84112

Research Site
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT03287908
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.