Phase 1 Study of Oral Selinexor Combined with Ruxolitinib and Methylprednisolone for Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the combination of selinexor, ruxolitinib, and methylprednisolone for patients with relapsed or refractory multiple myeloma. Selinexor is an oral drug that inhibits the nuclear export protein XPO1, leading to the buildup of tumor suppressor proteins and targeting myeloma cells. Ruxolitinib is an oral JAK12 inhibitor approved for myelofibrosis and has shown potential in combination with steroids for multiple myeloma. This phase 1 study aims to investigate the effectiveness of a lower dose of selinexor combined with ruxolitinib and methylprednisolone. The treatment involves a 33 dose escalation schedule with three dose levels. At dose level 0, patients receive 40 mg selinexor once weekly, 10 mg ruxolitinib twice daily for 28 days, and 40 mg oral methylprednisolone every other day. Dose level 1 increases selinexor to 60 mg weekly while maintaining ruxolitinib at 10 mg BID and methylprednisolone at 40 mg QOD. Dose level 2 maintains selinexor at 60 mg weekly, increases ruxolitinib to 15 mg BID, and continues methylprednisolone at 40 mg QOD. Participants will undergo assessments to determine the maximum tolerated dose and recommended phase 2 dose over 30 months. Researchers will monitor overall response rates, clinical benefit rates, and disease parameters during treatment. Safety and side effects will be closely observed. The study requires participants to adhere to scheduled visits and protocol requirements, including laboratory tests and disease evaluations throughout the study period.

A Trial of Selinexor, Ruxolitinib and Methylprednisolone