Status:
COMPLETED
Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. ...
Detailed Description
OBJECTIVES: * Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma. * Determine the incidence and severity of peripheral mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00287872
Start Date
September 1 2004
End Date
November 1 2010
Last Update
March 1 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410