About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
BMPC>/=20%
Disqualifiers
Meets criteria for symptomatic MM as defined by any of the following, determined to be related to the plasma cell disorder
Hypercalcemia (corrected serum calcium >11.0 mg/dL)
Renal insufficiency (creatinine >2.0 mg/dL)
Anemia (hemoglobin <10g/dL)
Trial design
Single group
Treatments tested in this trial
Selinexor
DrugLow-dose Selinexor for the Treatment of Intermediate to High-Risk Smoldering Multiple Myeloma
Treatment groups
Trial outcomes
Primary outcomes
Rate of progression to Multiple Myeloma
The study will assess how long participants will not have the cancer get worse while treated with selinexor
Secondary outcomes
Change in monoclonal protein (M-spike) or serum free light chains (sFLC)
M-spike will be measured in g/dL and sFLC will be measured in mg/dL
Progression free survival
The study will assess how long participants will not have the cancer get worse while treated with Selinexor
Rate of skeletal related events
rate of adverse events
Sponsors and contacts
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University of Rochester
Lead sponsor
Karyopharm Therapeutics Inc
Collaborator