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NCT00098475 · ClinicalTrials.gov registry record · Phase 3
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
A Phase 3 study of DS Stage I Multiple Myeloma and DS Stage II Multiple Myeloma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 452
- Enrollment target
- 20
- Study locations
NCT00098475: Active Phase 3 study of DS Stage I Multiple Myeloma and DS Stage II Multiple Myeloma, sponsored by National Cancer Institute (NCI).
NCT00098475 is a Phase 3 study of DS Stage I Multiple Myeloma and DS Stage II Multiple Myeloma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 452 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098475, a Phase 3 study of DS Stage I Multiple Myeloma and DS Stage II Multiple Myeloma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 452 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
Primary Outcome
Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Thalidomide
Study Locations (20)
Colorado
- The Medical Center of Aurora - Aurora
- Penrose-Saint Francis Healthcare - Colorado Springs
- Saint Joseph Hospital - Cancer Centers of Colorado - Denver
- Swedish Medical Center - Englewood
- Poudre Valley Hospital - Fort Collins
- Banner North Colorado Medical Center - Loveland Campus - Loveland
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Saint Jude Medical Center - Fullerton
- El Camino Hospital - Mountain View
- Kaiser Permanente-San Diego Mission - San Diego
Florida
- Holy Cross Hospital - Fort Lauderdale
- UF Health Cancer Institute - Gainesville - Gainesville
- Baptist MD Anderson Cancer Center - Jacksonville
- Mayo Clinic in Florida - Jacksonville
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Huntsville Hospital - Huntsville
Connecticut
- Danbury Hospital - Danbury
- Eastern Connecticut Hematology and Oncology Associates - Norwich
Alaska
- Providence Alaska Medical Center - Anchorage
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2004-11-03 |
| Est. Completion | 2026-10-23 |
| Phase | Phase 3 |
What the registry record for NCT00098475 still lists
NCT00098475 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 3 conditions, with DS Stage I Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00098475 names 20 study sites across 7 states, led by Colorado, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00098475 about?
NCT00098475 is a clinical study titled "Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma". This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate ...
What is the current status of trial NCT00098475?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2004-11-03. Estimated completion is 2026-10-23.
What conditions does trial NCT00098475 study?
This clinical trial studies the following conditions: DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma.
What interventions are being tested in trial NCT00098475?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Lenalidomide (DRUG), Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00098475?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00098475 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for DS Stage I 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 NCT00098475's enrollment target sits among peer trials
452 835th of 2000 higher than 1,165 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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