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
- 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
- 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 × 109/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 ×
- 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
HBV DNA test should be performed and if positive the subject will be excluded.
- Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by
- Ineligible for dexamethasone or dexamethasone is contraindicated.