Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
第3相
実施中(募集終了)
NCT00114101
| 対象疾患 | DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma, Refractory Multiple Myeloma |
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| 相 | 第3相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 460 名 |
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| 介入(薬剤) | Autologous Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Peripheral Blood Stem Cell Transplantation |
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| 開始日 | 2004年12月15日 |
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| 完了日 | 2012年12月31日 |
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| 結果公開日 | 2013年7月1日 |
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概要
This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.
Time to Progression
Duration of study (up to 10years) · months
| Lenalidomide Maintenance | 39 months |
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| Placebo Maintenance | 21 months |
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| p-value | <0.001 |
| Hazard Ratio (HR) | 0.36 (95% CI 0.26–0.53) |
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