Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed Salmon-Durie stage II or III multiple myeloma Untreated disease OR patient underwent prior therapy for this cancer that lasted no more than 2 weeks Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed) No evidence of cord compression requiring concurrent steroids PATIENT CHARACTERISTICS: Creatinine clearance ≥ 30 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment No known HIV positivity No peripheral neuropathy ≥ grade 2 No hypersensitivity to bortezomib, boron, or mannitol PRIOR CONCURRENT THERAPY: No prior bortezomib More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks No steroids within 14 days prior to study entry No concurrent corticosteroids except for the treatment of a nonmalignant condition May not exceed the equivalent dose of prednisone 10 mg/day No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery No other concurrent investigational agents
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Experimental
Bortezomib and Thalidomide
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.