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NCT00114101 · ClinicalTrials.gov registry record · Phase 3
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
A Phase 3 study of Refractory Multiple Myeloma and Smoldering Multiple Myeloma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
- 20
- Study locations
NCT00114101: Active Phase 3 study of Refractory Multiple Myeloma and Smoldering Multiple Myeloma, sponsored by National Cancer Institute (NCI).
NCT00114101 is a Phase 3 study of Refractory Multiple Myeloma and Smoldering Multiple Myeloma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 460 participants, above the 41-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (1022% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00114101, a Phase 3 study of Refractory Multiple Myeloma and Smoldering Multiple Myeloma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolv
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 |
What the registry record for NCT00114101 still lists
NCT00114101 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, above the 41-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (1022% higher).
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.
NCT00114101 names 20 study sites across 3 states, led by Colorado, California, Arizona.
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.
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).
Who is sponsoring clinical trial NCT00114101?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Refractory 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 NCT00114101's enrollment target sits among peer trials
460 1st of 67 higher than 67 of 67 other Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory 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.
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