This is an open-label, single-arm study of ATG-010 (selinexor) plus low-dose Dexamethasone (Sd) in patients with multiple myeloma previously treated with lenalidomide and bortezomib refractory to prior treatment with immunomodulatory agents and proteasome Inhibitors.
This is a single-arm, open-label, multicenter study of ATG-010 (Selinexor) plus low dose Dexamethasone dosed twice weekly each week in four-week cycles, in patients with triple-refractory MM. The population refractory for the primary efficacy analysis will contain only patients with triple-MM enrolled. PK analysis would be performed which would contain approximately 30% of the patients enrolled. Safety analyses will be performed on the overall population of patients who received at least one dose of study drug among triple-refractory patient populations. Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard care, or withdrawal, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle). Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Overall Response Rate (ORR)
The primary efficacy endpoint of ORR consists of proportion of patients who achieve PR, VGPR, CR, or sCR according to IMWG 2016 criteria: * CR means Negative IFE of serum and urine, disappearance of any soft tissue plasmacytomas (SPD), and \<5% plasma cells in bone marrow aspirates; * sCR means CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells); * VGPR means Serum and urine M-protein detectable by IFE but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; * PR means ≥50% reduction of serum M-protein plus reduction in 24-hour urine M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.
Time frame: 12 months
Progression-Free Survival (PFS)
To evaluate progression-free survival
Time frame: 12 months
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