S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •At least 1 of the following diagnoses:
• •* Multiple myeloma
• •* Stage II or III disease
• •* At least 1 of the following must be present:
• •* Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL
• •* Urinary M-protein (Bence-Jones) at least 200 mg/24 hours
• •* No IgM peaks except in patients who have physiologic criteria to support a diagnosis of multiple myeloma (e.g., bony lesions, myeloma kidney-cast nephropathy, absence of adenopathy \[unless pathology-proven to be plasma cell infiltration\])
• •* No monoclonal gammopathy of undetermined significance
• •* No indolent or smoldering myeloma
• •* No disease progression on prior thalidomide or dexamethasone
• •* Histologically confirmed primary systemic amyloidosis
• •* No senile, secondary, localized, dialysis-related, or familial amyloidosis
• •* No severe cardiac involvement
• •* No pre-exertional syncope, ventricular arrhythmia, or symptomatic pleural effusions associated with cardiac involvement
• •* Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria:
• •* Deposition of granular material containing free light chains/immunoglobulins that did not bind Congo red
• •* Evidence of plasma cell dyscrasia (i.e., monoclonal gammopathy in the serum or urine by immunofixation electrophoresis and/or clonal plasmacytosis) on bone marrow biopsy by immunohistochemistry and/or elevated serum-free light chain concentration
• •Must have been diagnosed within the past year
• •Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over (patients with amyloidosis only OR patients with amyloidosis and multiple myeloma OR patients with multiple myeloma only with poor renal function) OR
• •70 and over (patients with multiple myeloma only with or without poor renal function)
• •Performance status
• •Zubrod 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count at least 1,000/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic
• •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
• •SGOT or SGPT no greater than 2.5 times ULN
• •Renal
• •No hemodialysis within 2 hours of melphalan or stem cell infusion
• •Cardiovascular
• •See Disease Characteristics
• •Hemodynamically stable (i.e., systolic blood pressure \> 90 mm Hg in a lying position within the past 42 days)
• •No myocardial infarction within the past 6 months
• •No congestive heart failure
• •No arrhythmia refractory to medical therapy
• •LVEF greater than 45% by echocardiogram or MUGA
• •Pulmonary
• •See Disease Characteristics
• •No history of chronic obstructive or chronic restrictive pulmonary disease
• •Pulmonary function studies (e.g., FEV\_1 and FVC) at least 50% of predicted
• •DLCO at least 50% of predicted
• •Normal high resolution CT scan of the chest and acceptable arterial blood gases (i.e., PO\_2 greater than 70) required for patients unable to complete pulmonary function tests due to bone pain or fracture
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •* Multiple myeloma patients receiving thalidomide must use 2 methods of effective contraception for at least 4 weeks before, during, and for at least 4 weeks after discontinuation of thalidomide
• •HIV negative
• •No other concurrent significant medical condition
• •No concurrent uncontrolled life-threatening infection
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •See Disease Characteristics
• •Chemotherapy
• •See Disease Characteristics
• •Prior cumulative melphalan dose no more than 200 mg
• •No other concurrent chemotherapy
• •Endocrine therapy
• •See Disease Characteristics
• •No concurrent hormonal therapy
• •Radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •Not specified
• •Other
• •Recovered from prior therapy
• •Prior or concurrent bisphosphonates allowed