Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: Thalidomide; zoledronic acid
Intervention description: 200 mg orally on days 1-28 of 28 day cycle; 4 mg^2 by IV on day 1 every 84 days for 1 year and once per year thereafter
Intervention MeSH terms: Zoledronic Acid; Thalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma

Summary:

      RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone.
      Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is
      not yet know whether giving zoledronate together with thalidomide is more effective than
      zoledronate alone in treating multiple myeloma.

      PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well
      they work compared with zoledronate alone in treating patients with early stage multiple
      myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of multiple myeloma (MM)

               -  Previously untreated asymptomatic disease

               -  No requirement for immediate chemotherapy for active MM, such as hypercalcemia
                  from myeloma or painful bone lesions

          -  No solitary plasmacytoma

          -  Measurable or evaluable disease as defined by one of the following:

               -  Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

               -  More than 200 mg of monoclonal protein in the urine by 24-hour electrophoresis

               -  Measurable soft tissue plasmacytoma by physical exam with ruler or by MRI or
                  positron emission tomography/CT scan

                    -  If the only measurable lesion is the plasmacytoma, it must be ≥ 1.5 cm in 1
                       dimension

          -  Must have ≥ 10% plasma cells as measured on the bone marrow aspirate, bone marrow
             biopsy, or labeling index

          -  No amyloidosis

        PATIENT CHARACTERISTICS:

          -  Performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL

          -  Creatinine ≤ 2.0 mg/dL (elevation above normal range should not be felt to be related
             to myeloma)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 methods of effective contraception 4 weeks before, during,
             and for 4 weeks after completion of study treatment

          -  No uncontrolled infection

          -  No other active malignancy

          -  No New York Heart Association class III or IV heart disease

          -  No pre-existing neuropathy ≥ grade 2

          -  No concurrent major dental work

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Prior corticosteroids (for nonmalignant disorders) allowed

          -  Prior therapy with experimental agents not shown to have significant activity in MM,
             such as clarithromycin, dehydroepiandrosterone, and anakinra allowed

          -  No prior thalidomide or corticosteroids for MM

          -  No more than 3 doses of IV zoledronate or pamidronate within the past 12 months

          -  At least 3 months since prior radiotherapy, including radiotherapy for solitary
             plasmacytoma

          -  No concurrent oral bisphosphonate therapy for osteoporosis