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NCT03236792 · ClinicalTrials.gov registry record · Phase 1
Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03236792 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 28 participants.
The verdict
NCT03236792, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced in your bone marrow and cannot be broken down. It builds up in different organs preventing them from working well. The most commonly affected organs are the kidneys, heart, liver, spleen, nervous system, and digestive tract. Treatment with chemotherapy can stop the growth of abnormal cells that produce this abnormal protein. Decrease in amyloid protein in the body improves the function of the affected organs. The primary purpose of this study is to determine the safest dose of the medications and how well you tolerate them or the "maximum tolerated dose" (MTD). The study uses Ixazomib in combination with cyclophosphamide and dexamethasone to treat people with newly diagnosed AL amyloidosis. This combination of medications is an oral regimen that is taken over 6 cycles. The first part of study will determine the safety of this regimen and the second part of the study will determine how effective this combination of drugs is to treat your disease.
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03236792
The ClinicalTrials.gov registry entry for NCT03236792 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03236792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03236792 about?
NCT03236792 is a clinical study titled "Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis". Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced in your bone marrow and cannot be broken down. It builds up in different organs preventing them from working well. ...
What is the current status of trial NCT03236792?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-06-12. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT03236792?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT03236792?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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