Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

NCT00098475 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 452 participants
Start Date 2004-11-03
Est. Completion 2026-10-23
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

2,390 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00098475

The ClinicalTrials.gov registry entry for NCT00098475 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 452 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 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. 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: NCT00098475 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Colorado, California, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00098475?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Lenalidomide (DRUG), Thalidomide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00098475?

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 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.

Related

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