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.
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 three experimental arms. Arm I is given XTd regimen (ATG-010 60mg/d QW, Thalidomide 100mg/d and Dexamethasone 40mg/d QW) in approximately 30 subjects. Arm II is given XRd regimen (ATG-010 60mg/d QW, Lenalidomide 25mg/d d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects, Arm III is given XPd(ATG-010 60mg/d QW, Pomalidomide 4mg/d d1-21 and Dexamethasone 40mg/d QW ) in approximately 30 subjects,The three arms are 4 weeks per cycle and include a total of 12 cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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
100mg/d, Po. on day1-28
PO,Lenalidomide 25mg once daily from D1-21
Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle, PO.
Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOverall 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)
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
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