Selinexor in Combination With Immunomodulator （Thalidomide/Pomalidomide/Lenalidomide）in RRMM
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFebruary 27, 2023
February 1, 2023
3.9 years
June 25, 2021
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
ORR in each arm: partial response (PR) + very good partial response (VGPR) + complete response (CR)
Assessed from the date of first dose of study treatment until the date that PD assessed up to 12months
Secondary Outcomes (7)
Minimal Residual Disease (MRD)
12 months
Overall Survival (OS)
12 months
Progression-Free Survival (PFS)
12 months
Duration of Response (DOR)
12 months
Clinical Benefit Rate (CBR)
12 months
- +2 more secondary outcomes
Study Arms (3)
Arm I: Selinexor+Thalidomide+Dexamethasone
EXPERIMENTALArm 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.
Arm II: Selinexor+Lenalidomide+Dexamethasone
EXPERIMENTALArm 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.
Arm III: Selinexor+Pomalidomide+Dexamethasone
EXPERIMENTALArm 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Known and written informed consent (ICF) voluntarily.
- Age ≥ 18 years and ≤ 75 years.
- Patients with multiple myeloma who have received first-line treatment (induction, autologous transplantation and maintenance as the same first-line treatment) and achieved at least partial remission in induction.
- At or after accepting first-line regimen, subjects must have progression disease (PD) recorded which is determined by researcher according to IMWG criteria.
You may not qualify if:
- Left ventricular ejection fraction#LVEF #≥50% by an echocardiogram or MUGA scan in 42 days before the first administration
- Adequate hepatic function: total bilirubin \< 2× upper limit of normal (ULN) (for patients with Gilbert's syndrome, a total bilirubin of \< 3× ULN is required), AST \< 2.5× ULN, and ALT \< 2.5× ULN.
- Adequate renal function: estimated creatinine clearance ≥ 20 mL/min (calculated using the formula of Cockroft-Gault).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Measurable MM as defined by at least one of the following:
- Serum M-protein (SPEP) ≥ 10 g/L
- hours-Urinary M-protein excretion ≥ 0.2 g (200 mg)
- Serum FLC ≥ 100 mg/L with abnormal FLC ratio
- Expected survival is more than 6 months.
- Adequate hematopoietic function (no blood transfusion within 2 weeks and no G-CSF/GM-CSF supportive treatment within 1 week prior to screening test):
- Hemoglobin level ≥ 80 g/L
- ANC ≥ 1,000/mm3 (1.0×109/L)
- Platelet count ≥ 75,000/mm3 (75×109/L)
- Female patients of childbearing potential must meet below two criteria:
- must agree to use effective contraception methods since signature in ICF, throughout the study and for 3 months following the last dose of study treatment.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juan Dulead
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Related Publications (1)
Peng L, Shan T, Zhou X, Feng Z, Qiang W, Lu J, He H, Du J. Lowering the Selinexor Dose within the Pomalidomide and Dexamethasone Combination Regimen Elicits Fewer Side Effects While Comparable Efficacy Against Relapsed/Refractory Multiple Myeloma. Onco Targets Ther. 2025 Jun 6;18:695-703. doi: 10.2147/OTT.S516486. eCollection 2025.
PMID: 40496494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Du, M.D., Ph.D
Shanghai Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief physician, professor
Study Record Dates
First Submitted
June 25, 2021
First Posted
June 28, 2021
Study Start
January 27, 2022
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
February 27, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Study Protocol can be shared Starting 12 months after publication
- Access Criteria
- Study Protocol must not be shared with non-participants until after publication and must be authorized by the principal investigator and sponsors
All IPD results are used for publication,and can be shared with other investigators and sponsors