cc-5013 with or without dexamethasone in treating patients with primary systemic amyloidosis

Conditions: Multiple Myeloma

Summary: rationale: drugs such as cc-5013 and dexamethasone may be effective in treating primary systemic amyloidosis. purpose: this phase ii trial is studying cc-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.

objectives: primary * determine the tolerability of cc-5013 in patients with primary systemic (al) amyloidosis. * determine the objective hematologic response rate in patients treated with this drug. * determine amyloid organ disease response in patients treated with this drug. secondary * determine hematologic and amyloid organ disease response in patients who do not achieve a response to cc-5013 alone and are subsequently treated with cc-5013 and dexamethasone. * determine the toxicity of cc-5013 in combination with dexamethasone in these patients. outline: patients receive oral cc-5013 once daily on days 1-21. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients not achieving a hematologic response continue to receive cc-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. patients who maintain a hematologic response after 6 courses of combination therapy may receive cc-5013 alone in the absence of disease progression or unacceptable toxicity. patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study. patients are followed annually. projected accrual: a total of 15-25 patients will be accrued for this study within 5-12.5 months.

Eligibility criteria:
inclusion criteria: disease characteristics: * histologically confirmed primary systemic (al) amyloidosis * tissue amyloid deposits or positive fat aspirate * meets 1 of the following criteria for al type disease: * serum or urine monoclonal protein by immunofixation electrophoresis * plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype patient characteristics: age * 18 and over performance status * swog 0-2 life expectancy * not specified hematopoietic * white blood count\> 3,000/mm\^3 * hemoglobin \> 8 g/dl * platelet count \> 100,000/mm\^3 * absolute neutrophil count \> 1,000/mm\^3 hepatic * bilirubin ≤ 2 times upper limit of normal (uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2 times uln prior concurrent therapy: biologic therapy * prior thalidomide for al amyloidosis allowed chemotherapy * more than 4 weeks since prior cytotoxic chemotherapy endocrine therapy * prior steroids for al amyloidosis allowed radiotherapy * more than 4 weeks since prior radiotherapy surgery * prior surgery allowed other * recovered from all prior therapy exclusion criteria: * no secondary or familial amyloidosis * no multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen or lytic bone lesions * no prior cc-5013 renal * no dialysis cardiovascular * no symptomatic cardiac arrhythmia * no oxygen-dependent restrictive cardiomyopathy other * no untreated or uncontrolled infection * no other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast * no other serious medical illness that would preclude study participation * no history of hypersensitivity reaction to thalidomide * hiv negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception

Keywords: primary systemic amyloidosis