A Phase I/II Study of VLX1570 and Dexamethasone in Patients with Recurrent or Persistent Multiple Myeloma

Full Title

VLX1570 and Low-Dose Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma: A Clinical and Correlative Phase 1/2 Study

Purpose

Multiple myeloma typically responds to initial therapy and then often comes back. Doctors are therefore seeking more effective therapies, with the goal of learning how to cure this disease. One class of drugs used to treat multiple myeloma includes proteasome inhibitors. The proteasome breaks down proteins that are no longer useful to a cell. Proteasome inhibitors turn off the proteasome, causing the proteins to build up in the cell and resulting in cell death. Myeloma cells require a lot of proteins and an active proteasome to survive, so drugs that turn off the proteasome can inhibit myeloma growth.

Multiple myeloma may still come back after or stop responding to currently available proteasome inhibitors like bortezomib. In this study, researchers are evaluating the safety and preliminary effectiveness of a new proteasome inhibitor called VLX1570. This investigational drug inhibits the proteasome in a different way than other proteasome inhibitors.

Patients in this study will receive VLX1570 with dexamethasone, a standard drug used in the treatment of myeloma. VLX1570 is given intravenously, while dexamethasone is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma that has come back or continued to grow despite at least two prior regimens of therapy that included at least one immunomodulatory drug (such as thalidomide, lenalidomide, or pomalidomide) and one proteasome inhibitor (bortezomib or carfilzomib).
  • At least 2 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ola Landgren at 212-639-5153.

Protocol

14-274

Phase

I/II

Investigator

Co-Investigators

Locations