ATG-010(Selinexor) in Combination With Chemotherapy in RRMM

Sponsor
Chunyan Sun, MD
Study ID
NCT04877275
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor (80mg/d) — 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. Arm I：80mg/d QW ;
  • Selinexor (100mg/d) — 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. Arm II：100mg/d QW ;
  • Pegylated liposomal doxorubicin — DRUG
    25 mg/m\^2 intravenously on day 1 , QW
  • Dexamethasone — DRUG
    Dexamethasone 40mg/d QW
  • Cyclophosphamide — DRUG
    Cyclophosphamide：300mg/m2, d1 QW，

Study Details

This is a single-arm that includes two experimental arms,Selinexor(ATG-010) in Combination with Chemotherapy to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of ATG-010 in combination with chemotherapy in RRMM patients received at least one prior lines of therapy

Key Dates

Start date
May 21, 2021
Status verified
Dec 2023
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

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

Arms

  • Experimental: Arm I: Selinexor+Pegylated liposomal doxorubicin +Dexamethasone
    Arm I is given XDd regimen (ATG-010(Selinexor) 80mg/d QW, Pegylated liposomal doxorubicin 25mg/m2, d1and Dexamethasone 40mg/d QW) in approximately 25 subjects. 4 weeks per cycle and include a total of 12 cycles.
  • Experimental: Arm II: Selinexor+Cyclophosphamide+Dexamethasone
    Arm II is given XCd regimen (ATG-010 100mg/d QW, Cyclophosphamide 300mg/m2, d1and Dexamethasone 40mg/d QW). 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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