NCT01169337: Phase 3 -Lenalidomide or Observation in Asymptomatic High-Risk Smoldering Myeloma E3A06
Updated: May 23, 2022
ECOG E3A06
ECOG-ACRIN Cancer Research Group
ECOG E3A06
Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
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.
Sponsor
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01169337
Official Title: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
First Posted : July 26, 2010
Click here for details on ClinicalTrials.gov
J Clin Oncol; 2020 Apr
Conclusion: Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.
2019 ASCO Annual Meeting
Abstract 8001
* Lenalidomide (Revlimid)
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