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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2011-01-24 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 788-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (71% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.