What's the purpose of this trial?
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.
What will happen during the trial?
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.
You may be able to join this trial if you:
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.
- have measurable multiple myeloma disease as defined by the trial criteria.
- have received at least one, but no more than four prior lines of therapy for your myeloma.
- must have received therapy with an anti-CD38 antibody (e.g., daratumumab [Darzalex], isatuximb [Sarclisa]) as part of their immediate last line of therapy prior to joining this study.
- must have previously received at least two consecutive cycles of lenalidomide and a proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro]) given alone or in combination.
- must not have had prior treatment with a Selective Inhibitor of Nuclear Export (SINE) compound, pomalidomide, or elotuzumab.
- must not have had an autologous stem cell transplant in the previous 100 days, or an allogeneic stem cell transplant in the previous four months.
- must have adequate bone marrow, liver, kidney function as defined by the trial criteria.
Additional Trial Information
Phase 3
Enrollment: 222 patients (estimated)
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