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NCT00477971 · ClinicalTrials.gov registry record · Phase 3
Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT00477971: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT00477971 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 89 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477971, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having an autologous stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly. It is not yet known whether combination chemotherapy is more effective than chemotherapy followed by an autologous stem cell transplant in treating primary systemic amyloidosis. PURPOSE: This randomized phase III trial is studying the side effects and how well giving low-dose melphalan together with dexamethasone works compared with high-dose melphalan followed by an autologous stem cell transplant in treating patients with primary systemic amyloidosis.
Interventions
- DRUG dexamethasone
- PROCEDURE autologous hematopoietic stem cell transplantation
- DRUG melphalan
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2005-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00477971
The ClinicalTrials.gov registry entry for NCT00477971 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which dexamethasone is the first listed.
NCT00477971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00477971 about?
NCT00477971 is a clinical study titled "Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis". RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having an autologous stem cell transplant to replace the blood-forming cells destroyed by chemotherapy...
What is the current status of trial NCT00477971?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2005-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00477971?
The interventions under investigation include: dexamethasone (DRUG), autologous hematopoietic stem cell transplantation (PROCEDURE), melphalan (DRUG), filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00477971?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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