HD Melphalan and SCT in Patients With IGDD or LCDD
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Intervention: filgrastim; melphalan; Stem Cell Infusion
Intervention description: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC; 70-100 mg/m2/day will be administered intravenously on Days -3 and -2; 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: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: monoclonal immunoglobulin deposition disease; light chain deposition disease

Summary:

      RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells
      by stopping them from dividing or killing them. Giving colony-stimulating factors, such as
      G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the
      blood so they can be collected and stored. Chemotherapy is then given to prepare the bone
      marrow for the stem cell transplant. The stem cells are then returned to the patient to
      replace the blood-forming cells that were destroyed by the chemotherapy.

      PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given
      together with stem cell transplant and to see how well it works in treating patients with
      immunoglobulin deposition disease or light-chain deposition disease.
    

Eligibility criteria:

        Inclusion Criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed light-chain deposition disease based on the following
             criteria:

               -  Deposition of granular material containing free light-chain (FLC) immunoglobulins
                  that did not bind Congo red

               -  Evidence of a plasma cell dyscrasia, as defined by any of the following:

                    -  Monoclonal gammopathy in the serum or urine by immunofixation
                       electrophoresis

                    -  Clonal plasmacytosis on bone marrow biopsy by immuno-histochemical

                    -  Elevated serum levels of FLC

          -  Patients may enroll after stem cell collection (SCC) if all prestudy requirements are
             completed prior to starting SCC (i.e., ≥ 2.5 x 10^6 cells available for
             transplantation)

        PRIOR CONCURRENT THERAPY:

          -  Prior chemotherapy with alkylating agent allowed provided there is no evidence of
             myelodysplastic syndromes

          -  Prior total dose of melphalan < 300 mg

          -  More than 4 weeks since prior cytotoxic therapy and recovered

        PATIENT CHARACTERISTICS:

          -  Performance status 0-2

          -  Left Ventricular Ejection Fraction (LVEF) ≥ 45% within the past 90 days

          -  diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50%

        Exclusion Criteria:

          -  No overt multiple myeloma, as defined by any of the following:

               -  Greater than 30% bone marrow plasmacytosis

               -  Extensive (i.e., > 2) lytic lesions

               -  Hypercalcemia

          -  No myocardial infarction, congestive heart failure, or arrhythmia refractory to
             therapy within the past 6 months

          -  No prior malignancy except adequately treated basal cell or squamous cell skin cancer,
             carcinoma in situ of the cervix, adequately treated stage I or II cancer from which
             the patient is currently in complete response, or any other cancer from which the
             patient has been disease-free for the past 5 years

          -  No HIV positivity