Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

Inclusion Criteria:

Patients must have newly diagnosed MM confirmed by the presence of bone marrow plasmacytosis with > 10 percent plasma cells, sheets of plasma cells, or biopsy-proven plasmacytoma. Patients must have Durie-Salmon Stage IIA-B or IIIA-B. Patients with non-secretory myeloma are eligible. (These patients will not be included in the analysis of response rates, but will be assessed for toxicity and survival).
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3
≥ 18 years of age.
Signed informed consent form
Expected survival of greater than 8 weeks
Capable of swallowing study medication tablets
Capable of following directions regarding taking study medication, or has a daily care provider who will be responsible for administering study medication.
Patients will be eligible for study even if they lack socioeconomic access to autologous transplantation. (These patients will be identified prior to randomization so as not to confound study results).
All patients (in the event that they are randomized to the thalidomide/dexamethasone arm) must agree to take part in the "System for Education and Prescribing Safety" (S.T.E.P.S.)â„¢. They must sign a separate informed consent for this program.

Exclusion Criteria:

Elevated direct bilirubin > 2 mg/dl
Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN)
Absolute neutrophil count (ANC) <1000/mL, unless felt to be secondary to myeloma
Ongoing radiation therapy, or radiation therapy within 3 weeks prior to first treatment, unless the acute side effects associated with such therapy are resolved.
Prior treatment for multiple myeloma
Prior bisphosphonate use is allowed but they must be discontinued before starting treatment.
Concurrent uncontrolled serious infection
Patients with peripheral (sensory) neuropathy, grade 3 or higher
Life-threatening illness (unrelated to tumor)
History of any other ACTIVE and INVASIVE cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
Women of childbearing potential (unless utilizing birth control) or who are pregnant or nursing will be excluded from this study.
Patients with comorbid conditions that would contraindicate the use of vincristine, doxorubicin, dexamethasone, thalidomide, or zoledronate.
Plasma Cell Leukemia