Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma

Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug.

Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug. Condition:- Multiple Myeloma Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study Official Title: A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria:Active Multiple Myeloma Stage II or III Durie Salmon Measurable levels of myeloma paraprotein in serum or urine ECOG performance status of 0, 1, 2 Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective(for example hormonal or tubal ligation) and one barrier(for example latex condom, diaphragm) Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity Exclusion Criteria:Pregnant or lactating females Peripheral neuropathy greater than or equal to grade 2 of the NCI CTC. Prior history of malignancy unless subject has been free of disease for greater than or equal to 5 years Lab abnormality: Absolute neutrophil count less than 1,000 cells/mm cubed Lab abnormality: Platelet count less than 50,000 mm cubed Lab abnormality: Serum creatinine greater than 3.0 mg/dL Lab abnormality: Serum SGOT/AST or SGPT/ALT greater than 3 times the upper limit Lab abnormality: Serum total bilirubin greater than 2.0 mg/dL. Expected Total Enrollment: 436[1] Royal Brisbane Hospital[2] Frankston Hospital, Frankston, Victoria[3] The Alfred Hospital, Melbourne, Victoria[4] Celgene Corporation