Clinical trial NCT00049673 (phase 3, status: completed)
Conditions: multiple myeloma and plasma cell neoplasm
ICD codes: C96.20, C96.29, D47.09
Drugs: prednisone, thalidomide
SMILES: [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
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