BENITIONSClinical Trial Intelligence

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
第3相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数226 名
介入(薬剤)Clinical Observation, Lenalidomide, Quality-of-Life Assessment
開始日2011年1月24日
完了日2019年1月25日
結果公開日2021年5月18日

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

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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