A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

Inclusion Criteria:

- Active Multiple Myeloma Stage II or III Durie Salmon

- Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g
excreted in a 24-hour collection sample)

- Eastern Cooperative Oncology Group (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 ≥ to grade 2 of the NCI CTC.

- Prior history of malignancy unless subject has been free of disease for ≥ 3 years

- Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)

- Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L)

- Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)

- Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate
aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine
transaminase (ALT) >3.0 x upper limit of normal (ULN)

- Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)