Free from Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial): a Pilot Study of Minimal Residual Disease (MRD)-Driven Discontinuation of Maintenance (HEME-20)

Description

A pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative MM patients.This is a pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative Multiple Myeloma (MM) patients. Patients will be eligible if they have a diagnosis of active MM, have completed at least 2 years of maintenance therapy post-ASCT, and meet International Myeloma Working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Once eligibility is confirmed and informed consent is signed, MRD testing will be performed on routine bone marrow aspirate using standard of care next-generation sequencing (NGS) testing and will be defined at a threshold of 10-6. Patients who are in VGPR or CR and sustained MRD (defined as MRD-negative at two time points that are at least 1 year a

Trial Eligibility

Inclusion Criteria: * ECOG Performance Status equal to or less than 2 within 30 days prior to registration * Revised International Staging System (R-ISS) I,2 or 3 * Patients with multiple myeloma as defined by IMWG * Received at least 2 years of post ASCT maintenance (patients may have received any number of prior lines of therapy). * Maintenance therapy is defined as any anti-myeloma therapy initiated after ASCT to prevent disease recurrence and prolong time in remission (i.e., lenalidomide, bortezomib, RVD, etc.) * Disease response is VGPR or CR at the time of enrollment as defined by IMWG criteria. * Patients or their legally authorized representative 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 with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome * Prior organ transplant or condition requiring immunosuppressive therapy * Prior allogeneic hematopoietic cell transplant * Treatment with any investigational drug within 30 days prior to enrollment * Unable to sign an informed consent or their legally authorized represnetative

Study Info

Interventions

Locations Recruiting

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