Selinexor in Combination With Immunomodulator （Thalidomide/Pomalidomide/Lenalidomide）in RRMM

Sponsor
Juan Du
Study ID
NCT04941937
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg/d QW
  • Thalidomide — DRUG
    100mg/d, Po. on day1-28
  • Lenalidomide — DRUG
    PO,Lenalidomide 25mg once daily from D1-21
  • Pomalidomide — DRUG
    Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle, PO.
  • Dexamethasone — DRUG
    Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).

Study Details

Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This is a single-arm that includes three arms, Selinexor(ATG-010) in Combination with Immunomodulator (Thalidomide/ Pomalidomide/ Lenalidomide）and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients. To evaluate efficacy and safety of Selinexor in combination with Immunomodulator and Dexamethasone in RRMM patients received at least one prior lines of therapy.

Key Dates

Start date
Jan 27, 2022
Status verified
Feb 2023
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: Selinexor+Thalidomide+Dexamethasone
    Arm I is given XTd regimen Selinexor 60mg/d QW, Thalidomide 100mg/d, d1-28 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
  • Experimental: Arm II: Selinexor+Lenalidomide+Dexamethasone
    Arm II is given XRd regimen Selinexor 60mg/d QW, Lenalidomide 25mg/d, d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
  • Experimental: Arm III: Selinexor+Pomalidomide+Dexamethasone
    Arm III is given XPd regimen Selinexor 60mg/d QW, Pomalidomide 4mg/d, d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Assessed from the date of first dose of study treatment until the date that PD assessed up to 12months ]

Central Contacts

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