MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

Subjects must be ≥ 18 years of age at the time of screening.

Subjects must have a confirmed diagnosis of relapsed/refractory MM as per IMWG criteria (Rajkumar et al, 2014) and have exhausted standard of care regimens with proven clinical benefit, which include agents from the following anti myeloma therapies: PIs, IMIDs, and mAbs and have measurable disease with at least one of the following criteria:

Serum M-protein ≥ 0.5 g/dL
Urine M-protein ≥ 200 mg/24 hours
Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal.
Subjects must either be ineligible for or post-autologous stem cell transplant.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate organ and marrow functions as determined per protocol-defined criteria.

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:

Target Disease:

Subjects who have previously received an autologous stem cell transplant if less than 90 days have elapsed from the time of transplant or the subject has not recovered from transplant associated toxicities prior to the first scheduled dose of MEDI2228
Subjects who have previously received an allogeneic stem cell transplant
Central nervous system (CNS) involvement(including meningeal involvement) by MRI or cerebrospinal fluid exam

Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis

Medical History and Concurrent Diseases:

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results