This is a single-arm, phase II, open-label trial to investigate the effects of selinexor (S) in combination with daratumumab, lenalidomide, and dexamethasone (DRd) for first-line treatment of multiple myeloma (MM).
This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma. * In addition, the patient must meet one of the criteria in either 2a or 2b.
Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically at least one of the following:
Any one or more of the following:
Have measurable disease as defined by any of the following:
Patients who completed treatment for hepatitis C and have no detectable circulating hepatitis C virus (HCV) by hepatitis C RNA polymerase chain reaction (PCR) for at least 6 months prior to screening and have no detectable, may participate in the study.
Such patients will be required to undergo regular assessment for HCV reactivation during their participation in the study. Patients who test positive for HCV at any time during these assessments will be withdrawn from the study.
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening. If a patient's status changes (including laboratory results or receipt of additional medical records) after screening but before C1D1 such that he or she no longer meets all eligibility criteria, then the patient should be excluded from participation in the study.
Enrollment: 100 patients (estimated)View More
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