Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Thalidomide

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