Bortezomib With Melphalan and Prednisone for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bortezomib; Melphalan; Prednisone
Intervention MeSH terms: Prednisone; Bortezomib; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma

Summary:

      The purpose of this study is to assess the efficacy of bortezomib in combination with
      melphalan and prednisone to achieve complete responses for patients with previously untreated
      multiple myeloma compared to an historical control group. This trial will also evaluate the
      safety and toxicity of this regimen as well as evaluate the duration of response of this
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed multiple myeloma, defined as at least one
             of the following major criteria and one minor criterion or at least three minor
             criteria:

        Major Criteria Minor Criteria Plasmacytoma on tissue biopsy Marrow plasmacytosis 10-29%
        Marrow plasmacytosis ≥ 30% Monoclonal protein present, less than major criteria Monoclonal
        protein: Lytic bone lesions

        Immunoglobulin G (IgG) > 3.5 g/dl Decrease in uninvolved immunoglobulins:

        Immunoglobulin A (IgA) > 2 g/dl Immunoglobulin M (IgM) < 50 mg/dl Bence Jones ≥ 1 g/24 hr
        IgA < 100 mg/dl IgG < 600 mg/dl

          -  No prior therapy

          -  Life expectancy greater than 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status <3 (Karnofsky >40%

          -  Patients must have normal organ and marrow function. Patients with severe pancytopenia
             due to myeloma involvement of the bone marrow and patients with renal insufficiency
             (creatinine > 2 mg/dl) due to myeloma will also be included.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Pregnant women

          -  Patients may not be receiving any other investigational agents.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to bortezomib, melphalan, or other agents used in the study.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with bortezomib or other agents administered during the
             study.