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

Overview

This study will test whether stopping maintenance therapy in people with multiple myeloma in MRD-negative remission has the same effect on disease control as continuing this therapy. The study will look at whether people currently on maintenance therapy can safely stop this treatment and continue with active surveillance instead while keeping their MRD-negative remission status for at least 1 year.

SparkCures ID 1066
Trial Phase Observational Trial
Enrollment 50 Patients
Trial Sponsors
  • Memorial Sloan-Kettering Cancer Center
NCT Identifier

NCT04221178

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patients with plasma cell myeloma treated with any number of prior lines of therapy, who at the time of study enrollment have had sustained MRD-negativity at a given timepoint and a subsequent time point with an interval of 3 or more years while on continuous maintenance therapy. MRD-negativity is defined per the International Myeloma Working Group Consensus Panel.
  • MRD positivity will be defined by detection of 1 or more neoplastic plasma cells in 10^5 nucleated cells by flow cytometry as per IMWG criteria (i.e., sensitivity of 10-5)
  • Age >/= 18 years with ECOG performance status
  • Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care

Exclusion Criteria:

  • Patients found to be MRD-positive at time of screening
  • Patients with plasma cell leukemia or other disorder of plasma cell neoplasm
  • Patient who are receiving other therapy with the intent of treating myeloma with the exception of bisphosphonates
  • Patients being treated for another, potentially life-limiting malignancy with 3-year lead-in to study enrollment, with the exception of non-melanoma skin cancer or in situ malignancy
  • Prior organ transplant or condition requiring immunosuppressive therapy
  • Prior allogeneic hematopoietic cell transplant
  • Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or IV heart failure, uncontrolled coronary artery disease/arrhythmia, psychiatric or social disorder that would compromise compliance with the study schema

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Memorial Sloan Kettering Cancer Center

SparkCures Verified Accurate, up-to-date information. Learn more


Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Memorial Sloan Kettering Bergen

Montvale, NJ

Memorial Sloan Kettering Cancer Center

Commack, NY

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Memorial Sloan Kettering Cancer Center Westchester in West Harrison

West Harrison, NY

New Jersey
Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Memorial Sloan Kettering Bergen

Montvale, NJ

New York
Verified Memorial Sloan Kettering Cancer Center

SparkCures Verified Accurate, up-to-date information. Learn more


Memorial Sloan Kettering Cancer Center

Commack, NY

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Memorial Sloan Kettering Cancer Center Westchester in West Harrison

West Harrison, NY

Resources

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