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.
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.
Enrollment: 437 patients (estimated)View More
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