Selinexor for the Treatment of Patients with Intermediate and High-Risk Smoldering Multiple Myeloma
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.
• 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
• Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl \>/= 15 mL/min.
• Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)\>/=1.5 x10\^9/L, hemoglobin \>/=10g/dL, platelets \>/150x10\^9/L.
• Life expectancy of \>12 months.
• ECOG PS 0-1
• Subjects with reproductive potential must use 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 6 months after the study has closed. Subjects who are surgically sterile (e.g., history of bilateral tubal ligation, hysterectomy, or whos partner is sterile are not required to use additional modes of contraception.
• Ability to understand and willingness