What's the purpose of this trial?
The goal of this clinical trial is to determine which dose and treatment schedule of Selinexor combined with other treatments works best in the treatment of relapsed/refractory and newly diagnosed multiple myeloma.
This trial is currently open and accepting patients.
What will happen during the trial?
This is a multi-center, phase 1B (dose escalation)/phase 2 (dose expansion) study assessing how safe and effective Selinexor is in seven different combination therapies when treating relapsed/refractory and newly diagnosed multiple myeloma. Selinexor prevents your tumor suppressor proteins (TSPs), which are your cells’ natural cancer fighting proteins, from leaving the nucleus where they cannot fight a cancer cell. By Selinexor keeping your TSPs in the nucleus, it allows them to fight your cancer cells in the right place, leading to cancer cell death.
The goal of the dose escalation phase (phase 1) is to find the best dose and treatment schedule for each combination therapy. The goal of the dose expansion phase (phase 2) is to explore the doses and schedules determined in phase 1 in a larger group of participants. This trial is seeking to enroll approximately 146 - 209 patients in phase 1, and 309 patients in phase 2.
Participants in this study will receive one of seven different combination therapies. To accomplish this, this study is organized into different combination therapy groups, also called arms. Patients will be placed into an arm most appropriate for them by the study doctor depending on their diagnosis and previous treatment history.
This trial is currently recruiting for Arm 1, where participants receive an all-oral combination of Selinexor, dexamethasone and Pomalidomide.
Patients are also enrolling into additional arms:
Participants may continue to participate in the study as long as their myeloma isn’t getting worse and they aren’t experiencing bad side effects.
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.
- Patients must have measurable multiple myeloma as defined by the trial criteria.
- Depending on the arm of the trial patients join, they must meet a range of other criteria, including number of previous lines of therapy.
- Patients must not have non-secretory multiple myeloma.
- Patients must have adequate cardiac, liver, kidney, and bone marrow function as defined by the trial criteria.
- Patients must not have had an autologous transplant in the one month prior to joining, or an allogeneic transplant in the three months prior to joining.
Additional Trial Information
Phase 1/2
Enrollment: 437 patients (estimated)
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