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

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

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated 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.