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NCT00679367 · ClinicalTrials.gov registry record · Phase 2
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
A Phase 2 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00679367: Completed Phase 2 study, sponsored by Boston Medical Center.
NCT00679367 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00679367, a Phase 2 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis. PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Primary Outcome
Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a p
Interventions
- DRUG dexamethasone
- DRUG lenalidomide
- DRUG melphalan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2008-05 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT00679367 record still lists
NCT00679367 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which dexamethasone is the first listed.
NCT00679367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00679367 about?
NCT00679367 is a clinical study titled "Melphalan, Lenalidomide, and Dexamethasone 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 abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways...
What is the current status of trial NCT00679367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2008-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00679367?
The interventions under investigation include: dexamethasone (DRUG), lenalidomide (DRUG), melphalan (DRUG).
Who is sponsoring clinical trial NCT00679367?
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 NCT00679367's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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