A Phase II Study of Daratumumab in Patients with Newly Diagnosed Multiple Myeloma

Full Title

Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Newly-Diagnosed Multiple Myeloma: A Clinical and Correlative Phase II Study

Purpose

The purpose of this study is to evaluate the safety and effectiveness of daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone in patients newly diagnosed with multiple myeloma. Researchers will also assess the amount of myeloma cells remaining after treatment with daratumumab, a measure known as minimal residual disease (MRD). The information that doctors learn from the MRD tests will also be used to determine the best amount of time that patients should be on treatment.

Lenalidomide and dexamethasone have already been FDA-approved as treatments for newly diagnosed myeloma patients. Daratumumab and carfilzomib are approved for patients whose myeloma came back after prior therapy. The use of these drugs in combination in newly diagnosed patients is considered investigational.

Daratumumab and carfilzomib are given intravenously (by vein), and lenalidomide and dexamethasone are taken orally (by mouth).

Eligibility

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

  • Patients should be newly diagnosed with multiple myeloma. Patients who already started therapy elsewhere may have received up to one full cycle of treatment before going on this study, as long as their disease is still considered measurable.
  • Prior treatment with steroids, bisphosphonates, radiation therapy, and treatment for smoldering myeloma or multiple myeloma are permitted, but at least 2 weeks must pass between the completion of previous therapy and entry into the study.
  • Patients who were previously treated with carfilzomib for smoldering myeloma may not participate.
  • 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 212-639-5126.

Protocol

17-352

Phase

II

Investigator

Co-Investigators