Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Primary Systemic Amyloidosis
About this trial
This is an interventional treatment trial for Primary Systemic Amyloidosis
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (iododoxorubicin)
Patients receive iododoxorubicin IV over 15 minutes on days 1, 8, 15, and 22. Treatment repeats every 12 weeks for a total of 4 courses or a cumulative dose of 400 mg/m^2 in the absence of disease progression or unacceptable toxicity.