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

Completed · Not applicable

Conditions studied: Leukemia, Amyloidosis

In brief

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.

Key facts

Study ID

NCT00890552

Run by

Stanford University

People needed

25

Starts

2009-04-01

Expected to finish

2012-10-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Stanford University Cancer Institute — Stanford, California, United States

Full record on ClinicalTrials.gov

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