Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: rituximab; cyclophosphamide
Intervention MeSH terms: Cyclophosphamide; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such
      as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
      killing the cells or by stopping them from dividing. Giving rituximab together with
      cyclophosphamide may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with
      cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple
      myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of multiple myeloma, meeting 1 of the following criteria:

               -  High-risk disease in first remission, as defined by the following:

                    -  Beta-2 microglobulin > 5.0 mg/dL

                    -  Chromosome 13 deletion

               -  Primary refractory disease

               -  Relapsed disease after achieving a response to prior chemotherapy

          -  The following diagnoses are not allowed:

               -  POEMS syndrome

               -  Plasma cell leukemia

               -  Amyloidosis

               -  Nonsecretory myeloma

          -  No evidence of spinal cord compression

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  Has good organ function

          -  Is in good physical condition

          -  No active infection requiring antibiotics

          -  No other malignancy within the past 2 years except basal cell or squamous cell skin
             cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No persistently detectable donor cells after prior allogeneic stem cell
             transplantation

          -  No prior rituximab

        Chemotherapy

          -  See Disease Characteristics

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  At least 28 days since prior therapy