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NCT01169337 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Smoldering Multiple Myeloma and Light Chain Deposition Disease, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
226
Enrollment target
20
Study locations

NCT01169337: Active Phase 3 study of Smoldering Multiple Myeloma and Light Chain Deposition Disease, sponsored by National Cancer Institute (NCI).

NCT01169337 is a Phase 3 study of Smoldering Multiple Myeloma and Light Chain Deposition Disease that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 226 participants, below the 788-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01169337, a Phase 3 study of Smoldering Multiple Myeloma and Light Chain Deposition Disease, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
226 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events

Conditions Studied

Smoldering Multiple Myeloma Light Chain Deposition Disease

Interventions

  • OTHER Quality-of-Life Assessment
  • DRUG Lenalidomide
  • OTHER Clinical Observation

Study Locations (20)

California

  • Sutter Auburn Faith Hospital - Auburn
  • Alta Bates Summit Medical Center-Herrick Campus - Berkeley
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Mills-Peninsula Medical Center - Burlingame
  • Saint Jude Medical Center - Fullerton
  • Memorial Medical Center - Modesto
  • Palo Alto Medical Foundation-Camino Division - Mountain View
  • Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View
  • Sutter Cancer Research Consortium - Novato
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • Palo Alto Medical Foundation Health Care - Palo Alto
  • Eisenhower Medical Center - Rancho Mirage
  • Sutter Medical Center Sacramento - Sacramento

Alaska

  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2011-01-24
Est. Completion 2026-03-19
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT01169337 still lists

NCT01169337 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 788-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (71% lower).

The record links to 2 conditions, with Smoldering Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.

NCT01169337 names 20 study sites across 3 states, led by California, Alaska, Arizona.

Frequently Asked Questions

What is clinical trial NCT01169337 about?

NCT01169337 is a clinical study titled "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 can...

What is the current status of trial NCT01169337?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2011-01-24. Estimated completion is 2026-03-19.

What conditions does trial NCT01169337 study?

This clinical trial studies the following conditions: Smoldering Multiple Myeloma, Light Chain Deposition Disease.

What interventions are being tested in trial NCT01169337?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Lenalidomide (DRUG), Clinical Observation (OTHER).

Who is sponsoring clinical trial NCT01169337?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01169337 being conducted?

This trial has 20 study locations across Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Smoldering Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01169337's enrollment target sits among peer trials

226 8th of 20 higher than 13 of 20 other Smoldering Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Smoldering Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01169337, the US trial registry maintained by the National Library of Medicine. NCT01169337 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.