Clinical trial NCT00075608 (phase 2, status: terminated)
Conditions: multiple myeloma, plasma cell neoplasm
ICD codes: C90.01, C90.02, C90.00, C96.20, C96.29, D47.09
Drugs: melphalan
SMILES: N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        Inclusion criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed AL amyloidosis

               -  Persistent or recurrent disease after 1 course of prior high-dose chemotherapy

          -  Previously treated with autologous stem cell transplantation

          -  Significant initial improvement in organ function after prior high-dose melphalan,
             defined by at least 1 of the following:

               -  Complete hematologic remission (e.g., absence of monoclonal spike by
                  immunofixation in serum and urine AND less then 5% plasma cells in bone marrow
                  with no clonal predominance) OR partial hematologic response (e.g., any decrease
                  in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis)

               -  Greater than 50% reduction in proteinuria with preservation of creatinine
                  clearance

               -  Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in
                  liver size by physical exam

               -  Subjective neurologic improvement, as confirmed by neurologist

               -  Cardiac stabilization of disease confirmed by echocardiography defined as less
                  than 2 mm increase in mean wall thickness and/or less than 20 g increase in left
                  ventricular mass

               -  Improvement in performance status* NOTE: *This criteria alone does not constitute
                  significant improvement in organ function

          -  Prior stem cell yield must have been ≥ 2 x 10^6 CD34+ cells/kg

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

        Chemotherapy

          -  See Disease Characteristics

          -  No chemotherapy after first transplantation

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 65

        Performance status

          -  Southwest Oncology Group- 0-2

        Life expectancy

          -  More than 6 months

        Hematopoietic

          -  See Disease Characteristics

        Hepatic

          -  See Disease Characteristics

        Renal

          -  See Disease Characteristics

        Cardiovascular

          -  See Disease Characteristics

          -  Left ventricular ejection fraction ≥ 45% by multiple gated acquisition scan or
             echocardiogram

        Pulmonary

          -  diffusing capacity of lung for carbon monoxide ≥ 50%

        Exclusion Criteria:

          -  No myelodysplastic syndromes

          -  No abnormal bone marrow cytogenetics

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Acceptable toxicity from first transplantation, confirmed by the transplant team

          -  HIV negative

          -  No other concurrent malignancy except treated skin cancer