A Phase 2 interventional study of SPD：Selinexor Oral Tablet, Pomalidomide, Dexamethasone in Multiple Myeloma, sponsored by Peking University People's Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
This is a single-arm, open-label, multicenter, exploratory study initiated by investigator to evaluate the efficacy and safety of Selinexor (S) combined with pomalidomide (P) and dexamethasone (D) in the treatment of multiple myeloma with CNS involvement.
This is a single-arm, open-label, multicenter, exploratory study. The study plans to enroll patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle.
If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 21 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients diagnosed with multiple myeloma with CNS involvement to receive SPD treatment.
Drug: SPD：Selinexor Oral Tablet, Pomalidomide, Dexamethasone
Patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle. If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events.
Progression free survival
Assessed using the updated International Myeloma Working Group Response Criteria
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival
Assessed using the updated International Myeloma Working Group Response Criteria
Time frame: From date of enrollment until date of death from any cause, assessed up to 24 months.
Overall response rate
Assessed using the updated International Myeloma Working Group Response Criteria
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Adverse Events
Assessed using the CTCAE criteria.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Plan to share: No
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Peking University People's Hospital