A Phase Ib Study of Carfilzomib Give Once Weekly for Multiple Myeloma

Full Title

Phase 1b Study of Carfilzomib Administered Once Weekly in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma

Purpose

Carfilzomib is an anticancer drug given intravenously (by vein) twice a week, over two consecutive days, with lenalidomide and dexamethasone in patients with multiple myeloma that has come back or continued to grow despite prior therapy. In this study, researchers are assessing the safety and effectiveness of giving a higher dose of carfilzomib once a week with lenalidomide and dexamethasone in patients multiple myeloma.

Carfilzomib is a proteasome inhibitor. 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.

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 one to three prior regimens of therapy OR have newly diagnosed multiple myeloma that has not yet been treated.
  • At least 4 weeks must have passed since completion of prior chemotherapy and entry into the study. Patients may not have previously received carfilzomib.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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

15-280

Phase

I

Investigator

Co-Investigators

Locations