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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. 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.
Details
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | Mon Jun 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Sep 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- AL Amyloidosis
Interventions
- Ixazomib
- Cyclophosphamide
- Dexamethasone
Countries
United States