Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone versus Standard of Care to Achieve MRD Negativity in Patients with Newly Diagnosed Multiple Myeloma (ADVANCE study)

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Full Title

“A Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Standard of Care to Determine MRD Negativity in Patients with Newly-Diagnosed Multiple Myeloma (ADVANCE)”

Purpose

The standard of care for the treatment of people newly diagnosed with multiple myeloma is lenalidomide, bortezomib, and dexamethasone. In this study, researchers are evaluating the safety and effectiveness of two other combination drug regimens for newly diagnosed multiple myeloma: carfilzomib, lenalidomide, and dexamethasone (KRD) or KRD and daratumumab (KRD+DARA).

The primary aim of the study is to see if patients can achieve minimal residual disease (MRD) negativity after completing therapy. MRD negativity means that doctors cannot detect residual cancer cells in the bone marrow or blood after therapy, and patients don’t have any signs or symptoms of cancer. All of these drugs have been approved by the U.S. Food and Drug Administration to treat multiple myeloma, but some of the combinations being assessed in this study are considered investigational.

Patients in this study will be randomly assigned to receive either the standard treatment, KRD, or KRD+DARA. Some of these medications are taken orally (by mouth), some given intravenously (by vein), and some given by subcutaneous (under the skin) injection.

Eligibility

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

  • Patients must be newly diagnosed with multiple myeloma.
  • The study is open to both patients who are bone marrow transplant candidates as well as patients who are not candidates for transplant.
  • 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 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Ola Landgren at 212-639-5153.

Protocol

19-339

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators