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COMPLETED Phase 3

Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma

NCT00217438 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM). PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM

Interventions

  • DRUG melphalan
  • PROCEDURE peripheral blood stem cell transplantation
  • DRUG amifostine trihydrate
  • GENETIC fluorescence in situ hybridization
  • PROCEDURE bone marrow ablation with stem cell support

Study Locations (4)

Washington

  • VA Puget Sound Health Care System — Seattle
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle

California

  • Cedars-Sinai Medical Center — Los Angeles

New York

  • University of Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2005-07
Phase Phase 3

Sponsor

Fred Hutchinson Cancer Center

319 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00217438

The ClinicalTrials.gov registry entry for NCT00217438 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions — of which melphalan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00217438 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Washington, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00217438 about?

NCT00217438 is a clinical study titled "Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma". RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemoth...

What is the current status of trial NCT00217438?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2005-07.

What conditions does trial NCT00217438 study?

This clinical trial studies the following conditions: Refractory Multiple Myeloma, Stage III Multiple Myeloma, Stage II Multiple Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00217438?

The interventions under investigation include: melphalan (DRUG), peripheral blood stem cell transplantation (PROCEDURE), amifostine trihydrate (DRUG), fluorescence in situ hybridization (GENETIC), bone marrow ablation with stem cell support (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00217438?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00217438 being conducted?

This trial has 4 study locations across California, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial