Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis

Inclusion Criteria:

Histochemically confirmed amyloidosis by polarizing microscopy of greenbirefringent material in Congo red-stained tissue specimens

At least one of the following:

Demonstrable M-protein in serum or urine
Clonal population of plasma cells in bone marrow
Immunohistochemical stain with anti-light chain antisera of amyloid fibrils

Symptomatic organ involvement, including liver involvement, mild cardiac involvement, renal involvement, grade 1 or 2 peripheral neuropathy, or soft tissue involvement (including tongue)

No purpura or carpal tunnel syndrome as sole manifestation of disease

No clinically overt multiple myeloma defined as monoclonal bone marrow platelet concentration greater than 20% and at least one of the following:

Bone lesions
Anemia
Hypercalcemia
Performance status - ECOG 0-3 (3 allowed only if related to muscular infiltration by amyloid or peripheral neuropathy)
Platelet count at least 100,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Total bilirubin no greater than 2.0 mg/dL
Direct bilirubin no greater than 1.0 mg/dL
Alkaline phosphatase no greater than 4 times upper limit of normal (ULN)
AST or ALT no greater than 3 times ULN
Creatinine clearance at least 40 mL/min
Ejection fraction at least 50% by echocardiogram
No New York Heart Association class III or IV heart disease
No enzyme-documented myocardial infarction within the past 3 years
No chronic atrial fibrillation
No grade 2 or 3 atrioventricular block (Mobitz type I allowed)
No sustained (greater than 30 seconds) ventricular tachycardia, more than 1 episode of non-sustained ventricular tachycardia (3 consecutive ventricular beats), or frequent (more than 20 in 24 hours) ventricular pairs by 24-hour ambulatory electrocardiographic monitoring
No intraventricular septum greater than 16 mm by echocardiogram
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No other active malignancy except nonmelanoma skin cancer or cervical cancer
No psychiatric illness or social situation that would preclude study
No severe diarrhea (greater than grade 3) that is not controllable with medication or that requires total parenteral nutrition
More than 4 weeks since prior interferon alfa
No concurrent immunotherapy
More than 4 weeks since prior melphalan or other alkylating agents
No prior anthracycline exposure greater than 120 mg/m^2
Recovered from prior chemotherapy
No other concurrent chemotherapy
More than 4 weeks since prior high-dose dexamethasone
No concurrent radiotherapy
No concurrent investigational ancillary therapy