Clinical Drug Experience Knowledgebase

Criteria

Patient has confirmed clinical diagnosis of SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition: serum M-protein ≥3 g/dL or bone marrow clonal plasma cells (BMPC) greater than or equal to 10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline.
C: Absence of hypercalcemia, evidenced by a calcium <10.5 mg/dL.
R: Absence of renal failure, evidenced by a creatinine <2.0 mg/dL or calculated creatinine clearance (using the Modification of Diet in Renal Disease [MDRD] formula) >50 mL/min.
A: Absence of anemia, evidenced by a hemoglobin >10 g/dL.
B: Absence of lytic bone lesions on standard skeletal survey.
Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:
Serum monoclonal (M)-protein ≥3 g/dL.
BMPC greater than or equal to 10%.
Abnormal serum free light chain (FLC) ratio (0.26-1.65).
Patient has a life expectancy of greater than 6 months
Patient is human leukocyte antigen (HLA)-A2 positive.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patient has adequate bone marrow function, evidenced by a platelet count ≥75×109/L and an absolute neutrophil count (ANC) ≥1.0×109/L within 2 weeks before baseline.
Patient has adequate hepatic function, evidenced by a bilirubin ≤2.0 mg/dL and an alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5× the upper limit of normal (ULN) within 2 weeks before baseline.
If of child-bearing potential, patient agrees to use adequate birth control measures during study participation.
If a female of child-bearing potential, patient has negative urine pregnancy test results within 2 weeks before baseline and is not lactating.
Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study.

Exclusion Criteria:

Patient has symptomatic multiple myeloma, as defined by any of the following:
Lytic lesions or pathologic fractures.
Anemia (hemoglobin <10 g/dL).
Hypercalcemia (corrected serum calcium >11.5 mg/dL).
Renal insufficiency (creatinine >2 mg/dL).
Other: symptomatic hyperviscosity, amyloidosis.
Patient has abnormal cardiac status, evidenced by any of the following:
New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
Myocardial infarction within the previous 6 months.
Symptomatic cardiac arrhythmia requiring treatment or persisting despite treatment.
Patient is receiving any other investigational agent.
Patient has a current active infectious disease or positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
Patient has a history of or current auto-immune disease.
Patient has been vaccinated with live attenuated vaccines within 4 weeks before study vaccination.