a pilot study of lenalidomide, melphalan and dexamethasone in al amyloidosis

Conditions: Leukemia; Amyloidosis

Summary: this open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (mdr) to treat newly diagnosed or relapsed al amyloidosis, over the course of nine 28-day cycles.

the study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (mdr) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of mdr therapy, with the option of continuing treatment with lenalidomide as single-agent. patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.

Eligibility criteria:
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)