Bortezomib consolidation trial

FDA Resources. Arms and Interventions. Outcome Measures. The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT. Secondary Outcome Measures : assess effect of bortezomib consolidation on bone health [ Time Frame: At 1, 2, 3 and 9 months after start of treatment ] Summary of changes from baseline, after cycle 1,2 and 3 of bortezomib treatment and at the end of treatment for markers of bone formation and resorption.

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Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.

More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. To compare progression-free and overall survival among arms. To describe the adverse event profile of each arm. To compare sCR after 6 cycles and 24 cycles and quality of life among arms.

ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally PO on days 1 and 15 of courses and day 1 of courses , and dexamethasone PO on days 1 and 15 of courses and day 1 of courses In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response sCR is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry. Secondary Outcome Measures : Survival Time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ] The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.

Progression-free Survival [ Time Frame: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years ] The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Male patients, even if surgically sterilized ie, status postvasectomy , who:. Try the modernized ClinicalTrials. Learn more about the modernization effort.

Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Bortezomib consolidation post-ASCT appeared to equalize outcomes between older and younger patients who received prior treatment of differing intensity.

This suggests that the effect of consolidation may be relative and may depend on the composition and intensity of induction and high-dose therapy. Conclusion: Older patients receiving less intensive prior treatment could experience a larger PFS benefit from bortezomib consolidation.