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ACTIVE NOT RECRUITING Phase 3

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

NCT01169337 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01169337

The ClinicalTrials.gov registry entry for NCT01169337 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01169337 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alaska, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01169337?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Lenalidomide (DRUG), Clinical Observation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01169337?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial