A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

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.