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NCT01078454 · ClinicalTrials.gov registry record · Phase 3
Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT01078454: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01078454 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078454, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying melphalan and dexamethasone to see how well they work with or without bortezomib in treating patients with previously untreated systemic amyloidosis. 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. Bortezomib may stop the growth of plasma cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving melphalan together with dexamethasone is more effective with or without bortezomib in treating systemic amyloidosis.
Primary Outcome
sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), \<5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein \<100 mg/24 hr if baseline serum measurable; (4) urine M-component \<100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90%
Interventions
- DRUG dexamethasone
- DRUG melphalan
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-11-27 |
| Phase | Phase 3 |
What the finished NCT01078454 record still lists
NCT01078454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which dexamethasone is the first listed.
NCT01078454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078454 about?
NCT01078454 is a clinical study titled "Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis". This randomized phase III trial is studying melphalan and dexamethasone to see how well they work with or without bortezomib in treating patients with previously untreated systemic amyloidosis. Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth...
What is the current status of trial NCT01078454?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2010-11. Estimated completion is 2012-11-27.
What interventions are being tested in trial NCT01078454?
The interventions under investigation include: dexamethasone (DRUG), melphalan (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT01078454?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01078454's enrollment target sits among peer trials
11 1989th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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