A Pilot Study of Ixazomib and Dexamethasone to Treat Smoldering Multiple Myeloma

Full Title

Ixazomib (MLN9708) and Dexamethasone in High Risk Smoldering Multiple Myeloma: A Clinical and Correlative Pilot Study

Purpose

Doctors are working to refine the best way to care for patients with smoldering multiple myeloma, a form of the cancer which does not yet produce symptoms. In this study, they are evaluating the safety and preliminary effectiveness of combining the drugs ixazomib and dexamethasone in patients with smoldering multiple myeloma that has a high risk of becoming symptomatic. Ixazomib is approved for treating multiple myeloma; its use in this study is considered investigational. Dexamethasone is an anti-inflammatory drug commonly used in cancer care.

Ixazomib is a "proteasome inhibitor" similar to another drug called bortezomib. These drugs inhibit many proteins (known as proteasomes) that cancer cells need to survive and multiply. Unlike bortezomib, which is given intravenously (by vein), ixazomib is taken orally (by mouth). Dexamethasone is also taken orally.

Eligibility

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

  • Patients must have smoldering multiple myeloma that has a high risk of progressing to symptomatic myeloma.
  • Patients may not have previously received a proteasome inhibitor for multiple myeloma.
  • 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

15-294

Phase

Pilot

Investigator

Co-Investigators