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)
NCT ID: NCT04939142
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2021-07-12
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SVd (Selinexor+Bortezomib+dexamethasone)
Enrolled 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.
SVd (Selinexor+Bortezomib+dexamethasone)
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(Bortezomib+dexamethasone)
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Vd (Bortezomib+dexamethasone)
Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
Interventions
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SVd (Selinexor+Bortezomib+dexamethasone)
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 (Bortezomib+dexamethasone)
Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Confirmed MM with measurable disease per IMWG guidelines, and meet at least 1 of the following:
1. 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
2. Urinary M-protein level ≥ 200 mg/24 hours; or
3. Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal (Normal FLC ratio: 0.26 to 1.65).
4. 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.
5. Valid evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their last regimen.
6. Must have an ECOG Status score of 0, 1, or 2.
7. Renal function should meet the following criteria: creatinine clearance \[CrCl\] rates ≥ 20 mL/min (Calculated using the formula of Cockroft and Gault).
8. 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.
9. 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.
Exclusion Criteria
2. Active plasma cell leukemia.
3. Documented systemic light chain amyloidosis.
4. MM involving the central nervous system.
5. POEMS syndrome (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes).
6. Spinal cord compression related to MM.
7. Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral neuropathy with pain at baseline, regardless of whether the subject is currently receiving medication.
8. Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
9. Active graft versus host disease (After allogeneic stem cell transplantation) at screening.
10. Uncontrolled active infections requiring intravenous antibiotics, antivirals, or antifungal therapy in 2 weeks prior to C1D1.
11. Major surgery within 4 weeks prior to C1D1.
12. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
13. 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).
14. Pregnant or lactating women.
15. Life expectancy of \< 4 months.
16. Any active gastrointestinal dysfunction interfering with the subject's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
17. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
18. Contraindication to any of the required concomitant drugs or supportive treatments.
19. Any diseases or complications which may interfere with the study procedures.
20. Subject unwilling or unable to comply with the protocol.
18 Years
ALL
No
Sponsors
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Antengene Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Lu, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital OF USTC
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Peking University People'S Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital Army Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial People'S Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Shenzhen Second People'S Hospital
Shenzhen, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Affiliated Hospital of Nantong University
Nanchang, Jiangxi, China
The First Hospital of Nanchang
Nanchang, Jiangxi, China
Shengjing Hospital China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Qilu Hospital of Shangdong University
Jinan, Shangdong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital Zhejiang University of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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ATG-010-MM-002
Identifier Type: -
Identifier Source: org_study_id
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