A Phase II Study of Isatuximab for Patients with High-Risk Smoldering Multiple Myeloma

Full Title

Phase II Single Arm Trial of Isatuximab in Patients with High Risk Smoldering Multiple Myeloma

Purpose

Smoldering multiple myeloma is a precursor condition that does not produce symptoms. Patients with high-risk smoldering myeloma have a strong chance of developing multiple myeloma, a blood cancer. Isatuximab is an investigational drug (not approved by the FDA) that is an antibody which targets a protein on myeloma cells called CD38. It is given intravenously (by vein).

Isatuximab was previously shown to be effective in some patients whose myeloma relapsed. In this study, researchers are evaluating the safety and effectiveness of isatuximab in patients with smoldering myeloma, with the goal of preventing or slowing down the development of multiple myeloma.

Eligibility

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

  • Patients must have high-risk smoldering multiple myeloma that has not been treated.
  • 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 and to inquire about eligibility for this study, please contact Dr. Nikoletta Lendvai at 212-639-3368.

Protocol

18-077

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators