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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 12, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Relapsed or Refractory Multiple Myeloma
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 \[BIW\])

Trial Locations (33)

100043

Beijing Chao-Yang Hospital, Beijing

100044

Peking University People'S Hospital, Beijing

110004

Shengjing Hospital China Medical University, Shenyang

200025

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

200032

Zhongshan Hospital Fudan University, Shanghai

200233

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University, Shanghai

210029

Jiangsu Province Hospital, Nanjing

221000

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

230031

The First Affiliated Hospital OF USTC, Hefei

241001

The First Affiliated Hospital of Wannan Medical College, Wuhu

250012

Qilu Hospital of Shangdong University, Jinan

250021

Shandong Provincial Hospital, Jinan

266000

The Affiliated Hospital of Qingdao University, Qingdao

300052

Tianjin Medical University General Hospital, Tianjin

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hanzhou

310016

Sir Run Run Shaw Hospital Zhejiang University of Medicine, Hangzhou

315010

Ningbo First Hospital, Ningbo

330006

Affiliated Hospital of Nantong University, Nanchang

The First Hospital of Nanchang, Nanchang

400037

Xinqiao Hospital Army Medical University, Chongqing

410008

Xiangya Hospital Central South University, Changsha

410013

The Third Xiangya Hospital of Central South University, Changsha

430030

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510000

Guangdong Provincial People'S Hospital, Guangzhou

510060

Sun Yat-Sen University Cancer Center, Guangzhou

510515

Nanfang Hospital, Guangzhou

518035

Shenzhen Second People'S Hospital, Shenzhen

610072

Sichuan Provincial People's Hospital, Chengdu

v

Qingdao Municipal Hospital, Qingdao

09022836

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

All Listed Sponsors
lead

Antengene Corporation

INDUSTRY