2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Condition: Multiple Myeloma; Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Amyloidosis
Intervention: filgrastim; melphalan; autologous stem cell transplantation; stem cell infusion
Intervention description: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection; 140-200 mcg/kg IV over two days; infusion of previously collected stem cells on Day 0; infusion of previously collected stem cells on Day 0
Intervention MeSH terms: Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: primary systemic amyloidosis

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma
      cells, either by killing the cells or by stopping them from dividing. Having a stem cell
      transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses
      of chemotherapy to be given so that more plasma cells are killed. By reducing the number of
      plasma cells, the disease may progress more slowly.

      PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in
      treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
    

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