A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma

Fecha de inicio: 1 de octubre de 2012

Inclusion Criteria: Age ≥ 20 years at the time of signing the informed consent document Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted Able to adhere to the study visit schedule and other protocol requirements Previously untreated, symptomatic multiple myeloma Have measurable disease by protein electrophoresis analyses At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan Exclusion Criteria: Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study Any condition that confounds the ability to interpret data from the study Previous treatment with anti-myeloma therapy Pregnant or lactating females Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,000/microL (1.0 × 10^9/L ) Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) < 50,000 cells/microL (50 × 10^9/L) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 × upper limit of normal Renal failure requiring hemodialysis or peritoneal dialysis Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years Subjects who are unable or unwilling to undergo antithrombotic therapy. Peripheral neuropathy of ≥ grade 2 severity. Uncontrolled systemic fungal, bacterial, or viral infection Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease) Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. Ineligible for dexamethasone or dexamethasone is contraindicated.