To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
470
Thalidomide 50mg/day + Dexamethasone 40mg
Placebo + Dexamethasone 40mg
Time to tumor progression (TTP)
Time to tumor progression (TTP)
Time frame: Up to 3 years
Number of patients who survived
Number of patients who survived
Time frame: Up to 3 years
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Time frame: Up to 3 years
Myeloma response rate
Myeloma response determination criteria developed by Bladé et al 1998
Time frame: Up to 3 years
Number of participants with adverse events
Number of participants with adverse events
Time frame: Up to 3 years
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Clinical Research Consultants, Inc.
Hoover, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
UCLA School of Medicine
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James Berenson
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Jackson Memorial Hospital and Clinics
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