A Pilot Study of Lenalidomide and CC-486 with Radiation Therapy in Patients with Plasmacytoma

Share
Print

Full Title

A Pilot Study Evaluating Lenalidomide and CC-486 in Combination with Radiotherapy For Patients with Plasmacytoma (LENAZART study)

Purpose

The purpose of this study is to determine if combining the investigational drug CC-486 with lenalidomide and radiation therapy is a safe and effective treatment for plasmacytoma (a type of multiple myeloma). Patients newly diagnosed with plasmacytoma are usually treated with radiation therapy alone; those with multiple myeloma that has come back as a plasmacytoma usually receive radiation therapy and chemotherapy (such as lenalidomide).

CC-486 is an oral form of the drug azacitidine (taken by mouth); its use in this study is considered investigational. It works by changing the proteins produced by cancer cells. When CC-486 is combined with other cancer drugs, it may make cancer cells more likely to die. Researchers think that this combination therapy could boost the immune system’s ability to identify and destroy cancer cells, which could prevent plasmacytoma from developing into multiple myeloma or prevent multiple myeloma from getting worse.

Eligibility

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

  • Patients must have newly diagnosed plasmacytoma, or multiple myeloma that has come back as plasmacytoma after prior treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Urvi Shah at 212-639-7016.

Protocol

19-284

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator