University of Illinois at Chicago
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 sta…
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…
MRD testing through NGS Clonoseq will be performed as standard of care on all bone marrow samples. MRD negativity will be defined as observation of no templates at a sensitivity of 1 in a 1,000,000 (10-6) cells assessed, with a minimum of 1 million cells undergoing assessment. In addition, patients must be in VGPR/CR/PR as defined previously.
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