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Clinical Trial 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.


Clinical Trial Description

This study is a phase 1/2 study to assess safety and hematologic response rate of Ixazomib (MLN) in combination with Cyclophosphamide (CTX) and Dexamethasone (DEX). This is an open label multi-center, dose escalation safety study for patients with newly diagnosed AL Amyloidosis. A 3+3 design will be utilized to determine the MTD for MLN + CTX + DEX in 28-day treatment cycle. Treatment cycles will be repeated up to 6 cycles or until disease progression or until development of significant treatment-related toxicities. A total of up to 30 patients are planned to enroll into the study, with a maximum of 18 patients in the dose escalation arm and 18 patients in the MTD expansion arm. The cohort of 6 patients treated at the MTD during the dose expansion phase will also serve as the initial 6 patients for the expansion Phase II cohort. These 6 patients will contribute data to both the phase I dose escalation study and the phase II expansion study. To complete the Phase II cohort, an additional 12 new patients will need to be enrolled. MLN will be taken orally on days 1, 8, and 15 at doses of 3 mg or 4 mg. CTX will be taken orally on the same days with dose escalation from 300 mg up to 500 mg. DEX will be taken orally on days 1, 8, 15, 22 at 20 mg in the 28-day cycle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03236792
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 12, 2017
Completion date September 20, 2022

See also
  Status Clinical Trial Phase
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Recruiting NCT05451771 - Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis Phase 1/Phase 2
Completed NCT02574676 - Quality of Life (QOL) Registry for Patients With AL Amyloidosis
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Active, not recruiting NCT05199337 - Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01409148 - Radioimmunoimaging of AL Amyloidosis Phase 1
Active, not recruiting NCT04512235 - A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis Phase 3
Recruiting NCT05277493 - A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
Completed NCT02632786 - The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Phase 2
Completed NCT02841033 - Daratumumab for the Treatment of Patients With AL Amyloidosis Phase 1/Phase 2
Completed NCT04304144 - A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis Phase 2
Recruiting NCT01408225 - Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
Recruiting NCT04895917 - Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis Phase 2
Terminated NCT02489500 - Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib Phase 3
Completed NCT01570387 - A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis Phase 1/Phase 2
Terminated NCT03154047 - Study in Subjects With Light Chain (AL) Amyloidosis Phase 2
Recruiting NCT04392960 - Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis N/A
Recruiting NCT05898646 - Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial Phase 2
Enrolling by invitation NCT04210791 - Autologous Stem Cell Transplantation for Patients With AL Amyloidosis