Multiple Myeloma Clinical Trial
Official title:
VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma
Verified date | June 2014 |
Source | Sidney Kimmel Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Ghosh N, Ye X, Ferguson A, Huff CA, Borrello I. Bortezomib and thalidomide, a steroid free regimen in newly diagnosed patients with multiple myeloma. Br J Haematol. 2011 Mar;152(5):593-9. doi: 10.1111/j.1365-2141.2010.08534.x. Epub 2011 Jan 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Response to Treatment | Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or = 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), = 50% reduction of serum M-Protein and reduction in urinary M-protein by = 90% or to < 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR. | 1-6 months | |
Secondary | Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher) | Neuropathy was monitored using Total Neuropathy Score reduced (TNSr). | 1-6 months | |
Secondary | Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation | 1-6 months | ||
Secondary | The Time to Response | 1-6 months | ||
Secondary | Quality of Life | 0-6 months |
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