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

> **NCT01169337** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 226 (actual)

## Conditions studied

- Light Chain Deposition Disease
- Smoldering Multiple Myeloma

## Interventions

- **OTHER:** Clinical Observation
- **DRUG:** Lenalidomide
- **OTHER:** Quality-of-Life Assessment

## Key facts

- **NCT ID:** NCT01169337
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2011-01-24
- **Primary completion:** 2019-01-25
- **Final completion:** 2027-03-31
- **Target enrollment:** 226 (ACTUAL)
- **Last updated:** 2026-05-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01169337

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01169337, "Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT01169337. Licensed CC0.

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