Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

Inclusion Criteria:

Age 18 to 100 years at the time screening
Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma
Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
Patient must agree to take Lenalidomide with low dose dexamethasone as their initial therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Life expectancy of >6 months
Serum creatinine ≤ 2
ANC≥1000
Platelets ≥ 50,000
Total bilirubin ≤ 2 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)

Exclusion Criteria:

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results.
Concurrent enrollment in another clinical study, except for non-interventional, observational studies.
Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than Lenalidomide and dexamethasone.
Previous monoclonal antibody (mAb) or other treatment specifically directed against cluster of differentiation antigen 19 (CD19).
History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration.
Previous systemic cancer therapy for myeloma.
Any active secondary malignancy.
Human immunodeficiency virus (HIV) positive serology or acquired immune deficiency syndrome.
Active hepatitis B as defined by seropositivity for hepatitis B surface antigen. Or patients with positive hepatitis B core antibody titers.
Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis.
Documented current central nervous system involvement by multiple myeloma.
Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study.
Diagnosis of plasma cell leukemia
Diagnosis of POEMS syndrome
Diagnosis of Amyloidosis
Diagnosis of non-secretory myeloma