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 Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

NCT00644228 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Bortezomib

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center — Antioch
  • PCR Oncology — Arroyo Grande
  • Alta Bates Summit Medical Center-Herrick Campus — Berkeley
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
  • Mills-Peninsula Medical Center — Burlingame
  • Kaiser Permanente-Fremont — Fremont
  • Kaiser Permanente-Fresno — Fresno
  • Saint Jude Medical Center — Fullerton
  • Marin General Hospital — Greenbrae
  • Fremont - Rideout Cancer Center — Marysville
  • Providence Holy Cross Medical Center — Mission Hills
  • Palo Alto Medical Foundation-Camino Division — Mountain View
  • Sutter Cancer Research Consortium — Novato
  • Kaiser Permanente-Oakland — Oakland

Arizona

  • Mayo Clinic in Arizona — Scottsdale
  • University of Arizona Cancer Center-Orange Grove Campus — Tucson
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

Alaska

  • Providence Alaska Medical Center — Anchorage

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Trial Details

FieldValue
Enrollment Target 525 participants
Start Date 2008-07-28
Est. Completion 2026-09-18
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 NCT00644228

The ClinicalTrials.gov registry entry for NCT00644228 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 525 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: NCT00644228 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alaska. 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 NCT00644228 about?

NCT00644228 is a clinical study titled "Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma". This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system i...

What is the current status of trial NCT00644228?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 525 participants. The study started on 2008-07-28. Estimated completion is 2026-09-18.

What conditions does trial NCT00644228 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 NCT00644228?

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

Who is sponsoring clinical trial NCT00644228?

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 NCT00644228 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. 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