A Phase I/II Study of Isatuximab and Cemiplimab Immunotherapy in Patients with Recurrent or Persistent Multiple Myeloma

Full Title

TCD14906: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination with Cemiplimab in Patients with Relapsed/Refractory Multiple Myeloma

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drugs isatuximab and cemiplimab immunotherapy in patients with recurrent or persistent multiple myeloma. Isatuximab is an antibody which targets a protein on myeloma cells called CD38. It has been shown in prior studies to be effective against recurrent multiple myeloma. Cemiplimab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells.

Patients in this study will be randomly assigned to receive isatuximab alone, isatuximab plus cemiplimab every two weeks, or isatuximab plus cemiplimab every four weeks. Both drugs are given intravenously (by vein).

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 came back or continued to grow despite at least three prior regimens of therapy.
  • 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. Alexander Lesokhin at 212-639-5126.

Protocol

18-353

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators