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NCT00458822 · ClinicalTrials.gov registry record · Phase 2
Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis
A Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00458822: Completed Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00458822 is a Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 40 participants, below the 768-participant average among 26 other Multiple Myeloma and Plasma Cell Neoplasm trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458822, a Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.
Primary Outcome
patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 vis
Conditions Studied
Interventions
- DRUG dexamethasone
- DRUG bortezomib
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-02 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT00458822 record still lists
NCT00458822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 768-participant average among 26 other Multiple Myeloma and Plasma Cell Neoplasm trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Multiple Myeloma and Plasma Cell Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which dexamethasone is the first listed.
NCT00458822 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00458822 about?
NCT00458822 is a clinical study titled "Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis". The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to ...
What is the current status of trial NCT00458822?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2007-02. Estimated completion is 2015-03.
What conditions does trial NCT00458822 study?
This clinical trial studies the following conditions: Multiple Myeloma and Plasma Cell Neoplasm.
What interventions are being tested in trial NCT00458822?
The interventions under investigation include: dexamethasone (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00458822?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00458822 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma and Plasma Cell Neoplasm
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 NCT00458822's enrollment target sits among peer trials
40 13th of 26 higher than 14 of 26 other Multiple Myeloma and Plasma Cell Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma and Plasma Cell Neoplasm 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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