Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
3期
进行中(已停止招募)
NCT00644228
| 适应症 | DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma |
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| 分期 | 3期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 525 人 |
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| 干预(药物) | Bortezomib, Dexamethasone, Laboratory Biomarker Analysis, Lenalidomide |
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| 开始日期 | 2008年7月28日 |
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| 完成日期 | 2015年11月5日 |
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| 结果公布日 | 2017年7月6日 |
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摘要
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) |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。