Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: prednisone; thalidomide
Intervention description: Given orally; Given orally
Intervention MeSH terms: Thalidomide; Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 332.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the
      tumor. It is not yet known whether combining thalidomide with prednisone and giving them
      after autologous stem cell transplantation may be effective in treating multiple myeloma.

      PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how
      well they work compared to observation in treating patients who have undergone stem cell
      transplantation for multiple myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed multiple myeloma as evidenced by one of the following:

               -  Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells

               -  Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis

               -  Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the
                  M-protein criteria as below

          -  Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR

          -  Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only
             light chain disease (urine M-protein) was present at initial diagnosis

          -  Previously treated with autologous stem cell transplantation after high-dose melphalan
             (200 mg/m^2) within the past 60-100 days

               -  Received transplantation within 1 year of the beginning of initial chemotherapy
                  for multiple myeloma

               -  No evidence of disease progression

        PATIENT CHARACTERISTICS:

        Age

          -  16 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 6 months

        Hematopoietic

          -  No prior hereditary hypercoaguable disorder

          -  Granulocyte count at least 1,000/mm^3

          -  Platelet count at least 75,000/mm^3

        Hepatic

          -  Bilirubin no greater than 2 times upper limit of normal (ULN)

          -  AST and/or ALT no greater than 2 times ULN

          -  Alkaline phosphatase no greater than 2 times ULN

        Renal

          -  Creatinine no greater than 3 times ULN

        Cardiovascular

          -  No prior spontaneous deep vein thrombosis within the past 5 years

               -  Catheter-associated thrombus allowed

          -  No uncontrolled hypertension

        Pulmonary

          -  No prior pulmonary embolism within the past 5 years

        Other

          -  No other prior or concurrent malignancy except adequately treated squamous cell or
             basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more
             than 5 years prior to study entry and presumed cured

          -  No prior gastric ulceration or bleeding within the past 5 years

          -  No prior documented lupus anti-coagulant or anti-phospholipid antibody

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile female patients must use 2 effective methods of contraception for 1 month
             prior, during, and 1 month after study participation

          -  Male patients must use effective barrier contraception during and for 1 month after
             study participation

          -  No avascular necrosis of the hips or shoulders

          -  No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction
             (vincristine-induced sensory symptoms allowed)

          -  No diabetes with end-organ damage defined as:

               -  Documented diabetic neuropathy

               -  Retinal vascular proliferation requiring treatment

               -  Cardiovascular disease requiring active therapy

          -  Willing to complete quality of life questionnaires

          -  Employment does not prohibit the use of sedatives

          -  No other major medical illness or condition that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

          -  No prior double autologous or allogeneic hematopoietic stem cell transplantation

          -  No prior thalidomide

        Chemotherapy

          -  See Disease Characteristics

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  No other concurrent anti-cancer therapy

          -  No other concurrent investigational therapy