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NCT00793572 · ClinicalTrials.gov registry record · Phase 2
Autologous or Syngeneic Stem Cell Transplant Followed by Donor Stem Cell Transplant and Bortezomib in Treating Patients With Newly Diagnosed High-Risk, Relapsed, or Refractory Multiple Myeloma
A Phase 2 study of Refractory Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT00793572: Completed Phase 2 study of Refractory Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
NCT00793572 is a Phase 2 study of Refractory Plasma Cell Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 32 participants, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00793572, a Phase 2 study of Refractory Plasma Cell Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell transplant slows or stops the growth of cancer cells by preventing them from dividing or killing them. Stem cells that were harvested earlier from the patient's blood and frozen are then returned to the patient to replace the blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem cell transplant also prevents the patient's immune system from rejecting the donor's stem cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing cancer cells.
Primary Outcome
Number of subjects surviving without progressive disease post-transplant. Progressive disease criteria: 1. Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant. 2. Appearance of new lytic bone lesions or plasmacytomas.
Conditions Studied
Interventions
- DRUG Fludarabine Phosphate
- DRUG Bortezomib
- DRUG Cyclosporine
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-10 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT00793572 record still lists
NCT00793572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine Phosphate is the first listed.
NCT00793572 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT00793572 about?
NCT00793572 is a clinical study titled "Autologous or Syngeneic Stem Cell Transplant Followed by Donor Stem Cell Transplant and Bortezomib in Treating Patients With Newly Diagnosed High-Risk, Relapsed, or Refractory Multiple Myeloma". This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or refractory multiple myeloma ...
What is the current status of trial NCT00793572?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-10. Estimated completion is 2016-10.
What conditions does trial NCT00793572 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma.
What interventions are being tested in trial NCT00793572?
The interventions under investigation include: Fludarabine Phosphate (DRUG), Bortezomib (DRUG), Cyclosporine (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00793572?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00793572 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell Myeloma
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Where NCT00793572's enrollment target sits among peer trials
32 10th of 25 higher than 14 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell 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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