Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
第3相
実施中(募集終了)
NCT01169337
| 対象疾患 | Light Chain Deposition Disease, Smoldering 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 | 226 名 |
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| 介入(薬剤) | Clinical Observation, Lenalidomide, Quality-of-Life Assessment |
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| 開始日 | 2011年1月24日 |
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| 完了日 | 2019年1月25日 |
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| 結果公開日 | 2021年5月18日 |
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概要
This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)
Assessed every 4 weeks while on treatment up to 24 weeks · proportion of participants
| Arm A (Lenalidomide; Phase II) | 0.056 proportion of participants |
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2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)
Assessed every 3 months for 2 years · proportion of participants
| Arm A (Lenalidomide; Phase III) | 0.93 proportion of participants |
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| Arm B (Observation; Phase III) | 0.76 proportion of participants |
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