Expanded Access Study to Evaluate Carfilzomib in Patients with Relapsed or Refractory Multiple Myeloma

Protocol
11-158
Full Title
Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients with Relapsed and Refractory Disease
Purpose

The purpose of this study is to assess the safety and effectiveness of an investigational drug called carfilzomib in patients with multiple myeloma that has returned following or has stopped responding to standard treatment. Patients in this study will also receive dexamethasone to reduce side effects and to see if it enhances the effects of carfilzomib therapy. This study is an expanded access study, meaning the manufacturer of carfilzomib is making the drug available to more patients.

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 may inhibit myeloma growth.

Investigator
Lendvai, Nikoletta, MD
Eligibility

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

  • Patients must have symptomatic multiple myeloma that has returned or persists despite at least four prior regimens of therapy.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be at least 18 years of age.

For more information about this study and to inquire about eligibility, please contact Dr. Nikoletta Lendvai at 212-639-3368.

Disease(s)
Multiple Myeloma