CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 226 enrolled
Drug / intervention
Lenalidomide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01169337
NCT01169337Phase 3Active

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

National Cancer Institute (NCI)·interventional·Posted Jul 26, 2010·Updated May 1, 2026

In Brief

A Phase 3 clinical trial evaluating Clinical Observation, Lenalidomide, and 1 other intervention for Light Chain Deposition Disease and Smoldering Multiple Myeloma. Active but no longer recruiting, targeting 226 participants across 607 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland, Puerto Rico, United States
Collaborators--

Timeline

Phase 3Active
20112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 26, 2010
Enrollment StartJan 24, 2011
Primary CompletionJan 25, 2019
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 15.9 years ago

Interventions

Clinical Observationother

Undergo observation

Lenalidomidedrug

Given PO

Quality-of-Life Assessmentother

Ancillary studies