BENITIONSClinical Trial Intelligence

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

3상 진행 중(모집 완료) NCT01169337

대상 질환Light Chain Deposition Disease, Smoldering Multiple Myeloma
임상 단계3상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수226 명
중재(약물)Clinical Observation, Lenalidomide, Quality-of-Life Assessment
시작일2011년 1월 24일
완료일2019년 1월 25일
결과 공개일2021년 5월 18일

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

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
Arm B (Observation; Phase III)0.76 proportion of participants
p-value0.0005

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