Stopping Maintenance Therapy in People with Multiple Myeloma in MRD-Negative Remission

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Full Title

A Single-Arm, Biomarker-Based Prospective Study of Maintenance Therapy Cessation for Patients with Multiple Myeloma in Sustained MRD-Negative Remissions

Purpose

This study is being done in people with multiple myeloma that has been in “minimal residual disease (MRD)-negative remission” for at least three years and who have been receiving maintenance therapy. MRD-negative remission means doctors are not detecting cancer cells in the bone marrow or blood and patients don’t have any signs or symptoms of cancer.

Maintenance therapy is given to help keep cancer from coming back after it has disappeared following the first (initial) therapy. Among patients who have been MRD-negative for a few years, researchers think that stopping maintenance therapy may have the same effect on disease control as continuing this therapy. Maintenance therapy can have side effects when given over a long period of time, so researchers want to know if patients can take maintenance therapy for a shorter time.

This study is being done to see if people currently on maintenance therapy can safely stop this treatment and continue with active surveillance while keeping their MRD-negative remission status for at least one year. Active surveillance involves closely watching a patient’s condition but not giving any treatment unless there are changes in test results that show the cancer is getting worse.

Who Can Join

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

  • Patients must have multiple myeloma in MRD-negative remission for at least three years and have been receiving maintenance 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.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Neha Korde at 646-608-3708.

Protocol

19-422

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04221178