A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

INCLUSION CRITERIA

   - Newly diagnosed or relapsed AL amyloidosis

   - Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia

      - abnormal clonal dominance of plasma cells in the bone marrow

      - detection of a monoclonal gammopathy by immunofixation electrophoresis of serum
      and/or urine

      - an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy)

   - Measurable disease defined by an abnormal serum-free light chain or monoclonal protein
   by immunofixation

      - proteinuria ≥ 0.5 g/day, cardiac involvement with interventricular septal
      thickness ≥ 15 mm

      - hepatomegaly in the absence of congestive heart failure with elevated alkaline
      phosphatase

   - Age ≥ 18 years at the time of signing the informed consent form.

   - All previous cancer therapy must have been discontinued at least 4 weeks prior to
   treatment in this study

   - ECOG performance status of ≤ 3 at study entry

   - Laboratory test results:

      - Absolute neutrophil count ≥ 1.0 x 10e9 / L

      - Platelet count ≥ 75 x 10e9 / L

      - Creatinine clearance ≥ 15 mL/ minute

      - Total bilirubin ≤ 2-fold upper limits of normal

   - Disease-free of prior malignancies (excluding multiple myeloma) for ≥ 3 years with
   exception of:

      - currently treated basal cell

      - squamous cell carcinoma of the skin

      - carcinoma "in situ" of the cervix or breast.

   - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
   test

   - Females of childbearing potential must either:

      - commit to continued abstinence from heterosexual intercourse

      - acceptable methods of birth control and agree to ongoing pregnancy testing

   - Men must agree to use a latex condom during sexual contact with a FCBP even if they
   have had a successful vasectomy

   - All study participants must be registered into the mandatory RevAssist program, and
   able to comply with its requirements

   - Able to take aspirin (81 mg) daily • Understand and voluntarily sign an informed
   consent form

   - Able to adhere to the study visit schedule and other protocol requirements

EXCLUSION CRITERIA

   - Any serious medical condition that would prevent the subject from signing the informed
   consent form

   - Pregnant

   - breast-feeding females

   - Use of any other experimental drug or therapy within 28 days of baseline

   - Known hypersensitivity to thalidomide

   - Erythema nodosum if characterized by a desquamating rash while taking thalidomide or
   similar drugs

   - Any prior use of lenalidomide

   - Concurrent use of other anti-cancer agents or treatments

   - Known positivity for human immunodeficiency virus HIV)