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NCT00258245 · ClinicalTrials.gov registry record · Phase 1

Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

A Phase 1 study of Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Barbara Ann Karmanos Cancer Institute.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target
1
Study location

NCT00258245 is a Phase 1 study of Multiple Myeloma and Plasma Cell Neoplasm that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 5 participants, below the 770-participant average among 26 other Multiple Myeloma and Plasma Cell Neoplasm trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00258245, a Phase 1 study of Multiple Myeloma and Plasma Cell Neoplasm, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.

Interventions

  • DRUG dexamethasone
  • DRUG bortezomib
  • DRUG thalidomide
  • DRUG arsenic trioxide
  • DIETARY_SUPPLEMENT ascorbic acid

Study Locations (1)

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2005-05
Est. Completion 2008-04
Phase Phase 1

What the Registry Record Tells You About NCT00258245

The ClinicalTrials.gov registry entry for NCT00258245 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 770-participant average among 26 other Multiple Myeloma and Plasma Cell Neoplasm trials with a reported enrollment target (99% lower). The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma and Plasma Cell Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which dexamethasone is the first listed.

NCT00258245 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT00258245 about?

NCT00258245 is a clinical study titled "Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia". RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to th...

What is the current status of trial NCT00258245?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2005-05. Estimated completion is 2008-04.

What conditions does trial NCT00258245 study?

This clinical trial studies the following conditions: Multiple Myeloma and Plasma Cell Neoplasm.

What interventions are being tested in trial NCT00258245?

The interventions under investigation include: dexamethasone (DRUG), bortezomib (DRUG), thalidomide (DRUG), arsenic trioxide (DRUG), ascorbic acid (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00258245?

This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00258245 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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