Exclusion Criteria
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., <= the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
boolean
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
boolean
Pregnant or lactating females
boolean
Any of the following laboratory abnormalities
boolean
Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)
boolean
Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
boolean
Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
boolean
Renal failure requiring hemodialysis or peritoneal dialysis.
boolean
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
boolean
Basal cell carcinoma of the skin
boolean
Squamous cell carcinoma of the skin
boolean
Carcinoma in situ of the cervix
boolean
Carcinoma in situ of the breast
boolean
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
boolean
Patients who are unable or unwilling to undergo antithrombotic therapy.
boolean
Peripheral neuropathy of > grade 2 severity.
boolean
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
boolean
A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
boolean
A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
boolean