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NCT00790647 · ClinicalTrials.gov registry record · Phase 2
Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
A Phase 2 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00790647: Completed Phase 2 study, sponsored by Boston Medical Center.
NCT00790647 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00790647, a Phase 2 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.
Primary Outcome
complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy \<5% plasma cells with no clonal predominance of kappa or lambda isotype. Partial response: any one of the following 1. For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. 2. For patients with a detectable monoclonal peak on serum pro
Interventions
- DRUG melphalan
- BIOLOGICAL filgrastim
- DRUG bortezomib
- PROCEDURE Stem Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT00790647 record still lists
NCT00790647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which melphalan is the first listed.
NCT00790647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00790647 about?
NCT00790647 is a clinical study titled "Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis". RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can ...
What is the current status of trial NCT00790647?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2008-06. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00790647?
The interventions under investigation include: melphalan (DRUG), filgrastim (BIOLOGICAL), bortezomib (DRUG), Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00790647?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00790647's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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