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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Melphalan; Thalidomide

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)