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

Korábbi kezelés

• 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 or malignancies that have received definitive curative therapy
• 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

Más betegség

• Patients with plasma cell leukemia or other disorder of plasma cell neoplasm

Egyéb

• Patients found to be MRD-positive at time of screening

• 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 </= 2
• 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