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NCT00217438 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Refractory Multiple Myeloma and Stage III Multiple Myeloma, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 3
Development phase
130
Enrollment target
4
Study locations

NCT00217438: Completed Phase 3 study of Refractory Multiple Myeloma and Stage III Multiple Myeloma, sponsored by Fred Hutchinson Cancer Center.

NCT00217438 is a Phase 3 study of Refractory Multiple Myeloma and Stage III Multiple Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 130 participants, above the 46-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (183% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00217438, a Phase 3 study of Refractory Multiple Myeloma and Stage III Multiple Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 3
Development phase
130 participants
Enrollment target
4
Study locations

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

Primary Outcome

Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disea

Conditions Studied

Refractory Multiple Myeloma Stage III Multiple Myeloma Stage II Multiple Myeloma

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
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00217438 record still lists

NCT00217438 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (183% higher).

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.

NCT00217438 reports a single indexed study location in Washington, California, New York.

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.

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).

Who is sponsoring clinical trial NCT00217438?

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

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.

Learn More About Clinical Trials

Similar trials for Refractory Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00217438's enrollment target sits among peer trials

130 3rd of 67 higher than 63 of 67 other Refractory Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Multiple Myeloma 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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Related registry views

Source: ClinicalTrials.gov NCT00217438, the US trial registry maintained by the National Library of Medicine. NCT00217438 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.