University of Rochester
Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.
Plasma cell disorders are a spectrum of diseases ranging from monoclonal gammopathy of undetermined significance (MGUS), to smoldering multiple myeloma (SMM), to multiple myeloma (MM). Multiple myeloma is preceded by an asymptomatic precursor state in the majority of cases. While the vast majority of these patients do not progress to have symptomatic disease, there is an intermediate to high-risk subset of patients with SMM that do go on to meet criteria for MM, including hypercalcemia, anemia, renal insufficiency, and lytic bone lesions. There are numerous risk stratification systems that ha…
Inclusion Criteria: * Age \>/= 18 years * Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein \>/= 3 g/dL or BMPC \>10% but \<60%, or both. * Should not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder. * Should have 1 of the following risk factors to be considered intermediate risk and 2 or more risk factors to be considered high-risk: * BMPC\>/=20% * M-spike \>/= 2g/dL * Involved to uninvolved sFLC ratio of \>/= 20 * normal hepatic function within 28 days prior to C1D1 *…
Low-dose Selinexor for the Treatment of Intermediate to High-Risk Smoldering Multiple Myeloma
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