A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; dexamethasone
Intervention description: 25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle; 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Lenalidomide; dexamethasone; newly diagnosed multiple myeloma

Summary:

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

Eligibility criteria:

        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.