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

Trial ID or NCT#

NCT00890552

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Newly diagnosed or relapsed AL amyloidosis* Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia
  2. * 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
  3. * 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:
  4. * 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:
  5. * 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:
  6. * 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
    1. EXCLUSION CRITERIA
  8. * 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)
Exclusion Criteria:
  1. * 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)
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Investigator(s)

Ronald M Witteles
Ronald M Witteles
Cardiologist, Heart failure cardiologist
Professor of Medicine (Cardiovascular Medicine)

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov