Overview

Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients

Status:
Active, not recruiting
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma. More specifically, the study is focused on subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®) and showed worsening of their myeloma while receiving either one of these drugs in combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which means that ixazomib is currently being tested and is not yet approved by the United States Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for the treatment of multiple myeloma both on its own and in combination with other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Oncotherapeutics
Collaborators:
Millennium: The Takeda Oncology Company
Takeda
Treatments:
Ascorbic Acid
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Glycine
Ixazomib
Lenalidomide
Liposomal doxorubicin
Melphalan
Pomalidomide
Prednisone
Thalidomide
Vitamins