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NCT00054353 · ClinicalTrials.gov registry record · Phase 1

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 1 study of Refractory Multiple Myeloma, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target
2
Study locations

NCT00054353 is a Phase 1 study of Refractory Multiple Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 16 participants, below the 48-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00054353, a Phase 1 study of Refractory Multiple Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target
2
Study locations

Study Summary

This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.

Conditions Studied

Refractory Multiple Myeloma

Interventions

  • DRUG fludarabine phosphate
  • DRUG melphalan
  • DRUG cyclosporine
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil

Study Locations (2)

Washington

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle

Other

  • University of Torino - Torino

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2002-10
Est. Completion 2012-10-14
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

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What the Registry Record Tells You About NCT00054353

The ClinicalTrials.gov registry entry for NCT00054353 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 48-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (67% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT00054353 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Washington, Other.

Frequently Asked Questions

What is clinical trial NCT00054353 about?

NCT00054353 is a clinical study titled "Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma". This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan...

What is the current status of trial NCT00054353?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2002-10. Estimated completion is 2012-10-14.

What conditions does trial NCT00054353 study?

This clinical trial studies the following conditions: Refractory Multiple Myeloma.

What interventions are being tested in trial NCT00054353?

The interventions under investigation include: fludarabine phosphate (DRUG), melphalan (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00054353?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00054353 being conducted?

This trial has 2 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.