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NCT00135187 · ClinicalTrials.gov registry record · NA

Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma

A NA study of Multiple Myeloma, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT00135187 is a NA study of Multiple Myeloma that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00135187, a NA study of Multiple Myeloma, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

Patients are being asked to take part in this research study because they have multiple myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial therapy. For patients who have relapsed or are refractory to therapy, there is no agreed upon standard treatment. Treatment options include chemotherapy and, for some patients, bone marrow transplants. None of the available treatments are curative and investigators are continually looking for more effective treatments. This study involves treatment with a new combination of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other studies showed that an addition of Dexamethasone to VELCADE in patients not responding to VELCADE alone improved response rate. The proposed combination of all three drugs may improve efficacy and response. VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is approved for use in multiple myeloma. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with VELCADE, Doxil and Dexamethasone is an effective treatment, and also to determine the side effects that occur when this combination treatment is given.

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Doxil
  • DRUG VELCADE

Study Locations (1)

Michigan

  • University of Michigan Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-07
Est. Completion 2007-12
Phase NA

What the Registry Record Tells You About NCT00135187

The ClinicalTrials.gov registry entry for NCT00135187 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 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.

NCT00135187 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT00135187 about?

NCT00135187 is a clinical study titled "Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma". Patients are being asked to take part in this research study because they have multiple myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial therapy. For patients who have relapsed or are refractory to therapy, there is no agreed upon standard treatment. Treatm...

What is the current status of trial NCT00135187?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2004-07. Estimated completion is 2007-12.

What conditions does trial NCT00135187 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT00135187?

The interventions under investigation include: Dexamethasone (DRUG), Doxil (DRUG), VELCADE (DRUG).

Who is sponsoring clinical trial NCT00135187?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00135187 being conducted?

This trial has 1 study location across Michigan. 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

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