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NCT00097981 · ClinicalTrials.gov registry record · Phase 3

A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

A Phase 3 study of Multiple Myeloma, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
225
Enrollment target
20
Study locations

NCT00097981 is a Phase 3 study of Multiple Myeloma that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 225 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00097981, a Phase 3 study of Multiple Myeloma, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
225 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG Dexamethasone
  • DRUG Thalidomide
  • DRUG DOXIL

Study Locations (20)

Florida

  • - Boca Raton
  • - Jacksonville
  • - Miami
  • - Orange City
  • - Ormond Beach

California

  • - Fountain Valley
  • - Greenbrae
  • - La Verne
  • - Los Angeles

Maryland

  • - Baltimore
  • - Bethesda

Minnesota

  • - Minneapolis
  • - Saint Louis Park

Colorado

  • - Denver

Connecticut

  • - New London

Georgia

  • - Lawrenceville

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2005-01
Est. Completion 2009-10
Phase Phase 3

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

102 total trials

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What the Registry Record Tells You About NCT00097981

The ClinicalTrials.gov registry entry for NCT00097981 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (59% lower). The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.

NCT00097981 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT00097981 about?

NCT00097981 is a clinical study titled "A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma". The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of ...

What is the current status of trial NCT00097981?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2005-01. Estimated completion is 2009-10.

What conditions does trial NCT00097981 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT00097981?

The interventions under investigation include: Dexamethasone (DRUG), Thalidomide (DRUG), DOXIL (DRUG).

Who is sponsoring clinical trial NCT00097981?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00097981 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.