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NCT01383759 · ClinicalTrials.gov registry record · NA
Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis
A NA study of Amyloidosis and Light Chain Deposition Disease (LCDD or MIDD), sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT01383759: Completed NA study of Amyloidosis and Light Chain Deposition Disease (LCDD or MIDD), sponsored by Memorial Sloan Kettering Cancer Center.
NCT01383759 is a NA study of Amyloidosis and Light Chain Deposition Disease (LCDD or MIDD) that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 20 participants, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01383759, a NA study of Amyloidosis and Light Chain Deposition Disease (LCDD or MIDD), has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this clinical trial is to determine the toxicity and also the efficacy of a treatment that includes the following treatment: Two medications, bortezomib and dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged course of treatment with bortezomib and dexamethasone after transplantation. This type of treatment has been very effective in multiple myeloma. However, there is little experience with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD) or amyloidosis. The investigators and others have treated patients who have MIDD and amyloidosis with bortezomib and autologous stem cell transplantation and have had success with this treatment. But the combination of autologous transplant with BD given before and after the transplant is a new way of treating these diseases, which the investigators believe will be very effective.
Primary Outcome
of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Conditions Studied
Interventions
- DRUG Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone
Study Locations (5)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Rockville Centre - Rockville Centre
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-06-24 |
| Est. Completion | 2019-04-30 |
| Phase | NA |
What the finished NCT01383759 record still lists
NCT01383759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone is the first listed.
NCT01383759 lists 5 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01383759 about?
NCT01383759 is a clinical study titled "Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis". The goal of this clinical trial is to determine the toxicity and also the efficacy of a treatment that includes the following treatment: Two medications, bortezomib and dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged course of treatment with bortezomib and de...
What is the current status of trial NCT01383759?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2011-06-24. Estimated completion is 2019-04-30.
What conditions does trial NCT01383759 study?
This clinical trial studies the following conditions: Amyloidosis, Light Chain Deposition Disease (LCDD or MIDD), Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD), Monoclonal Immunoglobulin Deposition Disease (MIDD).
What interventions are being tested in trial NCT01383759?
The interventions under investigation include: Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01383759?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01383759 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyloidosis 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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