The goal of this clinical trial is to learn more about the safety and effectiveness of Selinexor in treating relapsed or refractory multiple myeloma. Researchers seek to accomplish this by comparing two different regimens, selinexor combined with pomalidomide and dexamethasone, and elotuzumab combined with pomalidomide and dexamethasone.
Pomalidomide and dexamethasone are oral drugs that are used to treat relapsed or refractory multiple myeloma. Pomalidomide and dexamethasone in combination with elotuzumab, which is given intravenously, is a standard therapy for relapsed or refractory multiple myeloma. Selinexor is an oral drug, and the all-oral combination of selinexor, pomalidomide, and dexamethasone, where none of the study drugs requires and infusion or injection, is being evaluated in this study and compared to elotuzumab, pomalidomide, and dexamethasone.
This trial is currently open and accepting patients.
This trial is open-label, which means that both the participants and health care professionals will know which treatments and doses they are receiving. Participants may continue to receive treatment as long as they do not develop bad side effects, and their myeloma does not get worse.
This clinical trial is being conducted in two different parts. In Part 1, researchers studied how safe and effective two different doses of selinexor were in combination with pomalidomide and dexamethasone compared to elotuzumab, pomalidomide and dexamethasone. Part 1 of this trial is no longer enrolling.
Part 2 of this clinical trial is currently enrolling, and is organized into two different groups, with a total of approximately 220 participants. In Part 2, researchers will compare the best dose of selinexor , pomalidomide and dexamethasone to elotuzumab, pomalidomide and dexamethasone in a larger group of patients.
Participants in Part 2 will be randomly assigned into one of two groups. Both groups will receive treatment organized into 28 day cycles.
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.
Enrollment: 222 patients (estimated)View More
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