Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients with Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged </= 65 Years

Newly diagnosed acitve MM; measurable disease (non-secretory pts elig if >/= 20% plasmacytosis or >3 focal plasmacytomas on skeletal survey/MRI); no more than 1 cycle of prior chemo for this disease; no prior melphalan; no radiation to > half pelvis; prior chemo/radiotherapy must have been completed >/= 4 wks prior to reg; 18-65 years; ejection fraction > 40% by MUGA or 2d ECHO; Zubrod PS 0-2 (or 3-4 based solely on bone pain); platelets >/= 150x10^9/L; ANC >/= 1.5x10^9/L unless myeloma related; total bilirubin </= 1.5xULN; no plans to receive dialysis; no Grade >/= 2 peripheral neuropathy; no known bortezomib, boron or mannitol sensitivity; no uncontrolled diabetes; pts must be offered participation in GEP; pts consenting to GEP must be offered participation in banking; must have serum bilirubin, creatinine, protein electrophoresis, and quantitative immunoglobulins, 24 hr urine for total protein and electrophoresis, serum free light chaines, serum and urine IFE and beta-2-microglobulin tests; pts must be aware of teratogenic potential of thalidomide and agree to comply with contraception guielines and STEPS program, no prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which pt has not received treatment for 1 yr prior to reg (other cancers acceptable if life expectancy is > 5 yrs); pts must give informed consent