BENITIONSClinical Trial Intelligence

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

Фаза 3 Идёт, набор закрыт NCT01169337

ЗаболеваниеLight Chain Deposition Disease, Smoldering Multiple Myeloma
ФазаФаза 3
СпонсорNational Cancer Institute (NCI)
СтатусИдёт, набор закрыт
Участники226 участн.
ВмешательствоClinical Observation, Lenalidomide, Quality-of-Life Assessment
Дата начала24.01.2011
Дата завершения25.01.2019
Публикация результатов18.05.2021

Кратко

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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