Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis

Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens and immunohistochemical proof of AL

Measurable disease of AL amyloidosis as defined by one of the following:

Serum monoclonal protein >=1.0 g by protein electrophoresis
>200 mg of monoclonal protein in the urine on 24 hour electrophoresis
Serum immunoglobulin free light chain & >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
ECOG performance status (PS) 0, 1, 2, or 3
>=18 years of age

The following laboratory values obtained <=14 days prior to registration:

Creatinine < = 3 mg/dL
Absolute neutrophil count >=1000/microliter
Platelet >=75000/microliter
Hemoglobin > = 8.0 g/dL
Symptomatic organ involvement with amyloid to justify therapy. This could include liver involvement, cardiac involvement, renal involvement, peripheral neuropathy grade 1, or soft tissue involvement. Must have more than purpura or carpal tunnel syndrome
Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function
Ability to provide informed consent
Anticipated life expectancy of at least 3 months

None of the following:

Pregnant women or women of reproductive ability who are unwilling to use effective contraception
Nursing women
Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
Myelosuppressive chemotherapy < 4 weeks prior to registration
Concomitant high dose corticosteroids
Grade 2 (or higher) peripheral neuropathy
Uncontrolled infection
Clinically overt multiple myeloma
Active malignancy
Prior hypersensitivity reaction to Thalidomide
Syncope within the past 30 days