Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
3상
진행 중(모집 완료)
NCT01169337
| 대상 질환 | Light Chain Deposition Disease, Smoldering Multiple Myeloma |
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| 임상 단계 | 3상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 226 명 |
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| 중재(약물) | Clinical Observation, Lenalidomide, Quality-of-Life Assessment |
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| 시작일 | 2011년 1월 24일 |
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| 완료일 | 2019년 1월 25일 |
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| 결과 공개일 | 2021년 5월 18일 |
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요약
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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