A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

June 14, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2028

Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
DRUG

SG301 Injection

Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.

DRUG

SG301 placebo

Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.

DRUG

pomalidomide

Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.

DRUG

dexamethasone

Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI \< 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.

Trial Locations (12)

100024

RECRUITING

Beijing Chaoyang Hospital of Capital Medical University, Beijing

215006

RECRUITING

The First Affiliated Hospital Of Soochow University, Suzhou

300060

RECRUITING

Tianjin Cancer University Airport Hospital, Tianjin

NOT_YET_RECRUITING

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310056

RECRUITING

The Second Affiliated Hospital Zhejiang University School Of Medicine, Hangzhou

430000

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

450000

RECRUITING

Henan Cancer Hospital, Zhengzhou

471000

RECRUITING

First Affiliated Hospital of Henan University of Science and Technology, Luoyang

510000

NOT_YET_RECRUITING

Guangzhou First People's Hospital, Guangzhou

NOT_YET_RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

710000

RECRUITING

The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital), Xi’an

030000

RECRUITING

Shanxi Provincial Hospital, Taiyuan

All Listed Sponsors
lead

Hangzhou Sumgen Biotech Co., Ltd.

INDUSTRY