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Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
NCT00114101 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.
Conditions Studied
Interventions
- DRUG Melphalan
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
Study Locations (20)
Colorado
- The Medical Center of Aurora — Aurora
- Boulder Community Foothills Hospital — Boulder
- Penrose-Saint Francis Healthcare — Colorado Springs
- AdventHealth Porter — Denver
- Presbyterian - Saint Lukes Medical Center - Health One — Denver
- Saint Joseph Hospital - Cancer Centers of Colorado — Denver
- Rose Medical Center — Denver
- Western States Cancer Research NCORP — Denver
- Swedish Medical Center — Englewood
- Saint Mary's Hospital and Regional Medical Center — Grand Junction
- Banner North Colorado Medical Center — Greeley
- Saint Anthony Hospital — Lakewood
- Sky Ridge Medical Center — Lone Tree
- Longmont United Hospital — Longmont
- Banner North Colorado Medical Center - Loveland Campus — Loveland
California
- City of Hope Comprehensive Cancer Center — Duarte
- University of California Davis Comprehensive Cancer Center — Sacramento
- UC San Diego Medical Center - Hillcrest — San Diego
- UCSF Medical Center-Mount Zion — San Francisco
Arizona
- Mayo Clinic in Arizona — Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2004-12-15 |
| Est. Completion | 2026-02-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00114101
The ClinicalTrials.gov registry entry for NCT00114101 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 460 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 5 conditions, with Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions — of which Melphalan 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: NCT00114101 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Colorado, California, 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 NCT00114101 about?
NCT00114101 is a clinical study titled "Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant". This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are i...
What is the current status of trial NCT00114101?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2004-12-15. Estimated completion is 2026-02-22.
What conditions does trial NCT00114101 study?
This clinical trial studies the following conditions: Refractory Multiple Myeloma, Smoldering Multiple Myeloma, DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00114101?
The interventions under investigation include: Melphalan (DRUG), Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00114101?
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 NCT00114101 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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