Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
Phase 3
Active, not recruiting
NCT00644228
| Condition | DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma |
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| Phase | Phase 3 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 525 participants |
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| Interventions | Bortezomib, Dexamethasone, Laboratory Biomarker Analysis, Lenalidomide |
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| Start date | Jul 28, 2008 |
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| Completion date | Nov 5, 2015 |
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| Results posted | Jul 6, 2017 |
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Summary
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
Progression-free Survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years · Months
| Arm I (Dexamethasone and Lenalidomide) | 30 Months |
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| Arm II (Dexamethasone, Lenalidomide, Bortezomib) | 43 Months |
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| p-value | 0.0018 |
| Hazard Ratio (HR) | 0.712 (95% CI 0.560–0.906) |
Open in BENITIONS
View on ClinicalTrials.gov
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