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NCT00401843 · ClinicalTrials.gov registry record · Phase 2

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 2
Development phase
307
Enrollment target
20
Study locations

NCT00401843 is a Phase 2 study of Multiple Myeloma that has completed, run by Janssen Research & Development. The registered enrollment target is 307 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT00401843, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
307 participants
Enrollment target
20
Study locations

Study Summary

The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG Placebo
  • DRUG Dexamethasone
  • DRUG Bortezomib
  • BIOLOGICAL Siltuximab

Study Locations (20)

Other

  • - Antwerp
  • - B-8000 Brugge
  • - Brussels
  • - Edegem
  • - Leuven
  • - Rio de Janeiro
  • - Bulgaria
  • - Pleven
  • - Plovdiv

California

  • - Greenbrae
  • - Los Angeles

New York

  • - New York
  • - Syracuse

Texas

  • - Dallas
  • - Houston

Indiana

  • - Indianapolis

New Mexico

  • - Albuquerque

North Carolina

  • - Chapel Hill

South Carolina

  • - North Charleston

Trial Details

FieldValue
Enrollment Target 307 participants
Start Date 2006-11-28
Est. Completion 2019-09-24
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT00401843

The ClinicalTrials.gov registry entry for NCT00401843 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 307 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 (44% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT00401843 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT00401843 about?

NCT00401843 is a clinical study titled "A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma". The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortez...

What is the current status of trial NCT00401843?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 307 participants. The study started on 2006-11-28. Estimated completion is 2019-09-24.

What conditions does trial NCT00401843 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT00401843?

The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Siltuximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00401843?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00401843 being conducted?

This trial has 20 study locations across California, Indiana, New Mexico, New York, North Carolina. 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

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.