MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

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

2. Subjects must have a confirmed diagnosis of relapsed/refractory MM as per IMWG
criteria (Rajkumar et al, 2014) or intolerant to all established regimens with proven
clinical benefit, which include agents from the following 3 classes of anti myeloma
therapies: PIs, IMIDs, and mAbs and have measurable disease with at least one of the
following criteria:

1. Serum M-protein ≥ 0.5 g/dL

2. Urine M-protein ≥ 200 mg/24 hours

3. Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum
FLC ratio is abnormal.

3. Subjects must either be ineligible for or post-autologous stem cell transplant.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

5. 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:

1. 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

2. Subjects who have previously received an allogeneic stem cell transplant

3. Central nervous system (CNS) involvement(including meningeal involvement) by MRI or
cerebrospinal fluid exam

4. 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:

5. 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