A Study of Evaluating the Safety and Efficacy of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
BENCH
A Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
1 other identifier
interventional
154
1 country
33
Brief Summary
This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2021
Typical duration for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedResults Posted
Study results publicly available
August 10, 2026
CompletedAugust 10, 2026
May 1, 2026
3.1 years
June 17, 2021
March 31, 2026
August 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
To evaluate progression-free survival
From date of randomization until the date of first documented PD (per IMWG criteria) or date of death, whichever occurs first. Participants without PD or death at the time of analysis are censored at the date of their last adequate disease assessment.
Secondary Outcomes (1)
Objective Response Rate (ORR)
From randomization until the earlier of IRC-confirmed PD or start of subsequent anti-myeloma therapy, assessed up to 2 years.
Study Arms (2)
SVd (Selinexor+Bortezomib+dexamethasone)
EXPERIMENTALEnrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
Vd(Bortezomib+dexamethasone)
EXPERIMENTALEnrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Interventions
Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
Eligibility Criteria
You may qualify if:
- Understand and voluntarily sign an informed consent form (ICF).
- Age ≥ 18 years.
- Confirmed MM with measurable disease per IMWG guidelines, and meet at least 1 of the following:
- Serum M-protein ≥ 0.5 g/dL (\> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin IgA, IgD myeloma, replaced by quantitative serum IgA, IgD levels; or
- Urinary M-protein level ≥ 200 mg/24 hours; or
- Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal (Normal FLC ratio: 0.26 to 1.65).
- Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
- Valid evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their last regimen.
- Must have an ECOG Status score of 0, 1, or 2.
- Renal function should meet the following criteria: creatinine clearance \[CrCl\] rates ≥ 20 mL/min (Calculated using the formula of Cockroft and Gault).
- Resolution of any clinically significant non-hematological toxicities (If any) from previous treatments to Grade ≤1 or baseline by C1D1. Subject with chronic, stable Grade 2 non hematological toxicities may be included following approval from the Medical Monitor.
- Female subjects of childbearing potential must have a negative serum pregnancy test at Screening. Female subjects of childbearing potential and fertile male subjects must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
You may not qualify if:
- Prior exposure to SINE compounds (Including ATG-010), or suspected allergy to SINE or similar drugs.
- Active plasma cell leukemia.
- Documented systemic light chain amyloidosis.
- MM involving the central nervous system.
- POEMS syndrome (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes).
- Spinal cord compression related to MM.
- Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral neuropathy with pain at baseline, regardless of whether the subject is currently receiving medication.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Active graft versus host disease (After allogeneic stem cell transplantation) at screening.
- Uncontrolled active infections requiring intravenous antibiotics, antivirals, or antifungal therapy in 2 weeks prior to C1D1.
- Major surgery within 4 weeks prior to C1D1.
- Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
- Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus deoxyribonucleic acid (HBV-DNA).
- Pregnant or lactating women.
- Life expectancy of \< 4 months.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The First Affiliated Hospital OF USTC
Hefei, Anhui, 230031, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100043, China
Peking University People'S Hospital
Beijing, Beijing Municipality, 100044, China
Xinqiao Hospital Army Medical University
Chongqing, Chongqing Municipality, 400037, China
Guangdong Provincial People'S Hospital
Guangzhou, Guangdong, 510000, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Shenzhen Second People'S Hospital
Shenzhen, Guangdong, 518035, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Affiliated Hospital of Nantong University
Nanchang, Jiangxi, 330006, China
The First Hospital of Nanchang
Nanchang, Jiangxi, 330006, China
Shengjing Hospital China Medical University
Shenyang, Liaoning, 110004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Qingdao Municipal Hospital
Qingdao, Shandong, v, China
Qilu Hospital of Shangdong University
Jinan, Shangdong, 250012, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 09022836, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, Shanghai Municipality, 200233, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Sir Run Run Shaw Hospital Zhejiang University of Medicine
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310003, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tingting Yu
- Organization
- Antengene Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Lu, PhD
Peking University People's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2021
First Posted
June 25, 2021
Study Start
July 12, 2021
Primary Completion
August 26, 2024
Study Completion
October 30, 2025
Last Updated
August 10, 2026
Results First Posted
August 10, 2026
Record last verified: 2026-05