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NCT00057564 · ClinicalTrials.gov registry record · Phase 3

A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

A Phase 3 study, sponsored by Celgene Corporation.

Completed
Registry status
Phase 3
Development phase
470
Enrollment target

NCT00057564: Completed Phase 3 study, sponsored by Celgene Corporation.

NCT00057564 is a Phase 3 study that has completed, run by Celgene Corporation. The registered enrollment target is 470 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00057564, a Phase 3 study, has completed, sponsored by Celgene Corporation.

COMPLETED
Registry status
Phase 3
Development phase
470 participants
Enrollment target

Study Summary

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Primary Outcome

Time to tumor progression (TTP)

Interventions

  • DRUG A (Thalidomide + Dexamethasone)
  • DRUG B (Placebo + Dexamethasone)

Trial Details

FieldValue
Enrollment Target 470 participants
Start Date 2003-02
Est. Completion 2013-08
Phase Phase 3
Celgene Corporation

40 total trials

What the finished NCT00057564 record still lists

NCT00057564 is an interventional study that assigns participants to a tested intervention. The registered 470 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 (39% lower).

The record links to 0 conditions, and to 2 interventions - of which A (Thalidomide + Dexamethasone) is the first listed.

NCT00057564 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00057564 about?

NCT00057564 is a clinical study titled "A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma". To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

What is the current status of trial NCT00057564?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 470 participants. The study started on 2003-02. Estimated completion is 2013-08.

What interventions are being tested in trial NCT00057564?

The interventions under investigation include: A (Thalidomide + Dexamethasone) (DRUG), B (Placebo + Dexamethasone) (DRUG).

Who is sponsoring clinical trial NCT00057564?

This trial is sponsored by Celgene Corporation, which has 40 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00057564's enrollment target sits among peer trials

470 813th of 2000 higher than 1,186 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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Source: ClinicalTrials.gov NCT00057564, the US trial registry maintained by the National Library of Medicine. NCT00057564 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.