Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: anti-thymocyte globulin; melphalan
Intervention description: 2.5 mg/kg; 16 mg/m^2
Intervention MeSH terms: Melphalan; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune
      system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such
      as melphalan, work in different ways to stop the growth of cancer cells, either by killing
      the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer
      cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may
      kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together
      with melphalan works in treating patients with relapsed multiple myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of multiple myeloma

             - Relapsed disease

          -  Must not be a candidate for stem cell transplantation, has refused transplantation, or
             has had stem cells collected previously

          -  Measurable disease, defined by ≥ 1 of the following:

               -  Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

               -  More than 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

               -  Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum
                  immunoglobulin kappa to lambda free light chain ratio

               -  Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-3

          -  Absolute neutrophil count ≥ 1,000/μL

          -  Platelet count ≥ 75,000/μL

          -  Hemoglobin ≥ 8.0 g/dL

          -  CD4 > 100/μL

          -  Creatinine ≤ 3 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active malignancy with the exception of nonmelanoma skin cancer or in situ cervical
             or breast cancer

          -  No uncontrolled infection

          -  No other co-morbidity that would interfere with patient's ability to participate in
             trial

        PRIOR CONCURRENT THERAPY:

          -  No limit to prior therapy

          -  At least 4 weeks since prior melphalan or other myelosuppressive agents

          -  At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or
             high-dose corticosteroids)

          -  No concurrent high-dose corticosteroids

               -  Concurrent chronic steroids (maximum dose 20 mg/day prednisone equivalent)
                  allowed if they are being given for disorders other than amyloid (e.g., adrenal
                  insufficiency or rheumatoid arthritis)

               -  Concurrent continuation of low level/stable steroid doses for replacement or
                  inhalation therapy allowed

          -  Concurrent bisphosphonates allowed

          -  No concurrent immunosuppressive medications such as cyclosporine

          -  No other concurrent investigational treatment

          -  No concurrent cytotoxic chemotherapy or external-beam radiotherapy>

          -  No other concurrent systemic anti-neoplastic therapy including, but not limited to,
             immunotherapy, hormonal therapy, or monoclonal antibody therapy

          -  No concurrent prophylactic hematopoietic growth factors (unless for treatment of an
             established cytopenia)