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
This is a single-arm and open-label phase II study of Relapsed/Refractory Multiple Myeloma patients who have received at least one prior lines of treatment therapy; This study includes two experimental arms. Arm I is given XDd regimen (ATG-010 80mg/d QW, Pegylated liposomal doxorubicin 25mg/m2, d1and Dexamethasone 40mg/d QW) in approximately 25 subjects. Arm II is given XCd regimen (ATG-010 100mg/d QW, Cyclophosphamide 300mg/m2, d1and Dexamethasone 40mg/d QW). Both arms are 4 weeks per cycle and include a total of 12 cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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 (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 ;
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGUnion Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Overall Response Rate (ORR)
ORR in each arm: partial response (PR) + very good partial response (VGPR) + complete response (CR)
Time frame: Assessed from the date of first dose of study treatment until the date that PD assessed up to 12months
Minimal Residual Disease (MRD)
To evaluate the minimal residual disease in CR and sCR patients
Time frame: 12 months
Overall Survival (OS)
The estimates of Kaplan-Meier
Time frame: 12 months
Progression-Free Survival (PFS)
Duration from start of study treatment to PD or death (regardless of cause), whichever comes first
Time frame: 12 months
Duration of Response (DOR)
Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first.
Time frame: 12 months
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR=ORR+Minor Response \[MR\])
Time frame: 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR=CBR+Stable Disease\[SD; for a minimum of 12 weeks\])
Time frame: 12 months
Number of Participants with Adverse Events
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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25 mg/m\^2 intravenously on day 1 , QW
Dexamethasone 40mg/d QW
Cyclophosphamide:300mg/m2, d1 QW,
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
NOT_YET_RECRUITINGTime frame: From first dose of study drug administration to end of treatment (up to 12 months)