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NCT00458705 · ClinicalTrials.gov registry record · Phase 2

Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
45
Enrollment target

NCT00458705: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00458705 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00458705, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
45 participants
Enrollment target

Study Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide, dexamethasone, and bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide and dexamethasone with or without bortezomib works in treating patients with multiple myeloma.

Primary Outcome

The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.

Interventions

  • DRUG dexamethasone
  • DRUG pegylated liposomal doxorubicin hydrochloride
  • DRUG bortezomib
  • DRUG thalidomide

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2006-11
Est. Completion 2011-04
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT00458705 record still lists

NCT00458705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).

The record links to 0 conditions, and to 4 interventions - of which dexamethasone is the first listed.

NCT00458705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00458705 about?

NCT00458705 is a clinical study titled "Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma". RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stoppi...

What is the current status of trial NCT00458705?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2006-11. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00458705?

The interventions under investigation include: dexamethasone (DRUG), pegylated liposomal doxorubicin hydrochloride (DRUG), bortezomib (DRUG), thalidomide (DRUG).

Who is sponsoring clinical trial NCT00458705?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00458705's enrollment target sits among peer trials

45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00458705, the US trial registry maintained by the National Library of Medicine. NCT00458705 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.