Selinexor, Pomalidomide, and Dexamethasone For Multiple Myeloma With CNS Involvement

Sponsor
Peking University People's Hospital
Study ID
NCT05478993
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPD：Selinexor Oral Tablet, Pomalidomide, Dexamethasone — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 12, 2022
Status verified
Jan 2024
Primary completion
Jul 10, 2024
Completion
Jul 10, 2025

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor, pomalidomide and dexamethasone
    Patients diagnosed with multiple myeloma with CNS involvement to receive SPD treatment.

Primary Outcome Measure

Progression free survival [ 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. ]

Central Contacts

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