Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the
 tumor. Prednisone may be effective in preventing relapse of multiple myeloma.

 PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide
 combined with prednisone following peripheral stem cell transplantation in treating patients
 who have multiple myeloma.
OBJECTIVES: I. Determine which dose of thalidomide (200 mg vs 400 mg) combined with
 prednisone is the optimally tolerated dose when used as maintenance therapy following
 autologous stem cell transplantation in patients with multiple myeloma. II. Compare the
 response rate in patients treated with these regimens. III. Compare the progression-free and
 overall survival in patients treated with these regimens.

 OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
 according to age (60 and over vs under 60). Within 60-100 days after autologous stem cell
 transplantation, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive
 lower dose oral thalidomide daily and oral prednisone every other day. Arm II: Patients
 receive higher dose thalidomide daily and oral prednisone every other day. Treatment
 continues for 2 years in the absence of disease progression or unacceptable toxicity.
 Patients are followed monthly for 6 months, every 3 months, and then at time of disease
 progression.

 PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per arm) will be accrued for this study
 within 17-21 months.
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Initial diagnosis must have
 been confirmed by one of the following prior to initial treatment for multiple myeloma:
 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 containing less
 than 10% plasma cells but with at least 1 bony lesion and the M-protein criteria outlined
 below Measurable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR If only
 light chain disease (urine M-protein only) present, then the urinary excretion of light
 chain (Bence Jones) protein must have been at least 1.0 g/24 hours at time of initial
 diagnosis Must have undergone autologous stem cell transplantation within 1 year of
 beginning initial chemotherapy for multiple myeloma Must be randomized 60-100 days after
 autologous stem cell infusion No evidence of progressive disease

 PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At
 least 6 months Hematopoietic: See Disease Characteristics Granulocyte count at least
 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 1.5
 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal:
 Creatinine no greater than 3 times ULN Cardiovascular: No uncontrolled hypertension Other:
 Not pregnant or nursing Negative pregnancy test Fertile female patients must use 2
 effective methods of contraception (1 barrier and 1 hormonal) during and for 1 month after
 study Fertile male patients must use effective barrier contraception during and for 1 month
 after study No other medical condition that would preclude long term use of prednisone or
 thalidomide No other malignancy within the past 5 years except adequately treated squamous
 cell or basal cell skin cancer or carcinoma in situ of the cervix No diabetes with end
 stage organ damage No history of gastric ulceration or bleeding No avascular necrosis of
 the hips No peripheral neuropathy causing symptomatic dysfunction Sensory symptoms induced
 by vincristine allowed No demonstrated hypersensitivity to thalidomide or its components No
 other major medical illness that would increase risk or preclude study No employment that
 prohibits the use of sedatives (due to known effect of thalidomide)

 PRIOR CONCURRENT THERAPY: Biologic: See Disease Characteristics No prior thalidomide
 Chemotherapy: See Disease Characteristics Endocrine: Not specified Radiotherapy: Not
 specified Surgery: Not specified Other: No other concurrent anticancer treatment No other
 concurrent investigational therapy