A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: CC-5013; Lenalidomide
Intervention description: Oral 25mg daily on Days 1-21 every 28 days.; Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.
Intervention MeSH terms: Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Revlimid

Summary:

      The study evaluated the safety of Lenalidomide monotherapy in participants with advanced
      multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose
      dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and
      CC-5013-MM-010 due to the development of documented disease progression or the inability to
      tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose
      dexamethasone without grade 3 or 4 toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age ≥ 18 years at time of signing the informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Participants with multiple myeloma and were enrolled in either THAL-MM-003,
             CC-5013-MM-009, or CC-5013-MM-010 and discontinued study therapy with thalidomide and
             high-dose dexamethasone or high-dose dexamethasone alone due to:

        documented disease progression OR inability to tolerate the lowest dosing regimen allowed
        on previous protocol without a grade 3 or 4 toxicity.

          -  Eastern Cooperative Oncology Group (ECOG) performance status score 0,1,2

          -  Recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (NCI CTC)

          -  Females of child-bearing potential (FCBP) must agree to using two methods of
             contraception

        Exclusion Criteria:

          -  Prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior
             development of a grade ≥ 3 rash or desquamation while taking thalidomide National
             Cancer Institute Common toxicity Criteria (NCI CTC)

          -  Use of any standard/experimental anti-myeloma therapy within 28 days of randomization
             or use of any experimental non-drug therapy within 56 days of initiation of drug
             treatment

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             will prevent the participant from signing the informed consent form or that will place
             the participant at an unacceptable risk for toxicity if he/she participates in the
             study.

          -  Pregnant or lactating females.

          -  Prior therapy with CC-5013; prior history of malignancies, other than multiple myeloma
             (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the
             cervix or breast), unless subject has been free of disease for ≥ 5 years

          -  More than 4 months has elapsed since the last dose of study drug was administered on
             study Tal MM-003, CC-5013-MM-009, CC-5013-MM-010

          -  Absolute neutrophil count (ANC) <1,000cells/mm^3 (1.0 X 10^9/L)

          -  Platelet count <75,000/mm^3 (30 X 10^9/L) for those with <50% if the bone marrow
             nucleated cells re plasma cells; Platelet count <30,000/mm^3 (30 X 10^9/L) for those
             with <50% if the bone marrow nucleated cells re plasma cells

          -  Serum creatinine >2.5mg/dL; serum SGOT/AST or SGPT/ALT x upper limits of normal (ULN)

          -  Serum total bilirubin >2.0mg/d/L