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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 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.
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2005-07 |
| Phase | Phase 3 |
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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, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (183% higher). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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