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ACTIVE NOT RECRUITING
NCT04939142
PHASE3

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)

Sponsor: Antengene Corporation

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-07-12

Completion Date

2025-12-31

Last Updated

2025-02-11

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

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)

COMBINATION_PRODUCT

Vd (Bortezomib+dexamethasone)

Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])

Locations (33)

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