NCT01169337: Phase 3 -Lenalidomide or Observation in Asymptomatic High-Risk Smoldering Myeloma E3A06

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)

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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

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Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

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Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma

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.

E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma.

2019 ASCO Annual Meeting

Abstract 8001

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* Lenalidomide (Revlimid)

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