A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone
Intervention description: Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle; Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients
      with previously treated multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must understand and voluntarily sign the informed consent form

          -  Age ≥ 20 years at the time of signing the informed consent form

          -  Subjects with previously treated multiple myeloma defined as follows:

               -  Subjects must have received at least 1 prior anti-myeloma drug treatment regimen;
                  and

               -  Considered to have progression of disease (PD) that occurred either during or
                  following the completion of the last anti-myeloma treatment regimen utilized
                  prior to enrollment into this study

          -  Measurable levels of M-protein in serum (greater than or equal to 0.5 g/dL [5g/L]) or
             urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

          -  Must be able to adhere to the study visit schedule and other protocol requirements

          -  Females of childbearing potential (FCBP) must agree to use one or more of the
             following forms of contraception or abstain from heterosexual contact completely and
             have the male partners use a condom on the occasion of heterosexual contact in the
             following periods below:

               -  For at least 28 days before starting study drug (in particular, the subject must
                  abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide).

               -  During the treatment phase (including the dose withholding period) For at least
                  28 days after the discontinuation/completion of the study drug (Methods of
                  contraception)

               -  Birth control pills

               -  Intrauterine device (IUD)

               -  Bilateral tubal ligation (FCBP must be referred to a health care provider who is
                  familiar with contraceptive methods, if needed).

          -  Male subject must agree to use a condom during sexual contact with female irrespective
             of pregnancy potential

          -  Subjects must agree that study drug must be immediately discontinued, if pregnancy or
             a positive pregnancy test does occur in a female study subject or the partner of a
             male study subject during study participation

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Subjects with a history of acute myocardial infarction within the past 6 months before
             starting the study drugs

          -  Subjects with any history or concurrent conditions of deep vein thrombosis or
             pulmonary embolus within the past 3 years before starting study drugs

          -  Subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or
             other active infectious diseases

          -  Subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma

          -  Subjects with posterior subcapsular cataracts

          -  Subjects with peripheral neuropathy of ≥Grade 2

          -  Subjects with any history or concurrent conditions which the Principal Investigator /
             subinvestigators consider inappropriate for participation in this study, and subjects
             with a serious disease or a mental disease, which is considered to become more risky
             if the subjects participate in this study.

          -  Subjects with a history of desquamative (blistering) rash while taking thalidomide

          -  Subjects with a history of using lenalidomide

          -  Subjects who have used thalidomide within 28 days before starting the study drugs

          -  Subjects with a history of hypersensitivity to dexamethasone

          -  Subjects who discontinued treatment due to grade 3 or 4 toxicity from high dose
             dexamethasone

          -  Subjects with a surgical wound after a visceral surgery performed recently

          -  Subjects who have undergone radiation therapy within 14 days before starting the study
             drugs

          -  Subjects who have used a chemotherapeutic agent, an immunomodulating agent or a study
             drug (a drug not commercially available) intended for the treatment of multiple
             myeloma (MM) within 28 days before starting the study drug

          -  Subjects with any history or concurrent conditions of malignancies, other than MM,
             unless the subject has been free of the disease for 3 years:

               -  Basal cell carcinoma of the skin,

               -  Squamous cell carcinoma of the skin,

               -  Carcinoma in situ of the cervix,

               -  Carcinoma in situ of the breast,

               -  Incidental histologic finding of prostate cancer Tumor, Lymph Nodes, Metastasis
                  (TNM) stage of T1a or T1b)

          -  Known human immunodeficiency virus (HIV) infection or HIV-1 positivity

          -  Subjects who have been diagnosed as an hepatitis b virus (HBV) carrier

          -  Subjects who are applicable to any of the following abnormal laboratory findings:

               -  Absolute neutrophil count : < 1,000 /μL (1.0×10^9 /L)

               -  Platelet count: <75,000 /μL (75×10^9 /L)

               -  Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)
                  or alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT): >
                  3.0 times the upper limit of the standard range

               -  Creatinine clearance: < 30 mL/min