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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: Completed Phase 1 study of Refractory Multiple Myeloma, sponsored by Fred Hutchinson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2002-10 |
| Est. Completion | 2012-10-14 |
| Phase | Phase 1 |
What the finished NCT00054353 record still lists
NCT00054353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 48-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (67% lower).
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 a single indexed study location in 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.
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 NCT00054353's enrollment target sits among peer trials
16 57th of 67 higher than 11 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.
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