Clinical trial NCT00052884 (phase 1, status: terminated)
Conditions: drug/agent toxicity by tissue/organ, multiple myeloma and plasma cell neoplasm
ICD codes: T86.91, T86.92, T86.93, Z52.9, Z94.89, Z94.9, T86.90, C96.20, C96.29, D47.09
Drugs: amifostine trihydrate, melphalan
SMILES: NCCCNCCSP(O)(O)=O, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Reason stopped: 
    slow accrual and changes in clinical practice
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed amyloidosis

               -  No secondary familial or localized amyloidosis

          -  Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or
             urine

          -  No primary amyloidosis manifested only by carpal tunnel syndrome or purpura

          -  Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic
             individual not considered an amyloid syndrome

               -  Amyloid syndromes include any of the following:

                    -  Hepatomegaly

                    -  Cardiomyopathy

                    -  Nephrotic range proteinuria

                    -  Peripheral or autonomic neuropathy

          -  No multiple myeloma defined by 1 of the following:

               -  Presence of lytic bone disease

               -  More than 30% bone marrow plasma cells

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 70

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  See Disease Characteristics

          -  Total or direct bilirubin no greater than 2.0 mg/dL

          -  Alkaline phosphatase no greater than 4 times upper limit of normal

        Renal

          -  See Disease Characteristics

          -  Creatinine less than 3.0 mg/dL

        Cardiovascular

          -  See Disease Characteristics

          -  Ejection fraction at least 45% by echocardiogram

          -  No New York Heart Association class III or IV heart disease

          -  Systolic blood pressure ≥ 90 mmHg

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection

          -  No other malignancy within the past 5 years except surgically treated carcinoma in
             situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 4 weeks since prior interferon

        Chemotherapy

          -  At least 4 weeks since prior melphalan

          -  Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight)

        Endocrine therapy

          -  At least 4 weeks since prior dexamethasone

        Radiotherapy

          -  No prior radiotherapy for amyloidosis

        Surgery

          -  Not specified

        Other

          -  No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour
             after amifostine administration

          -  No other prior treatment