Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06508983
PHASE3

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

Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-06-14

Completion Date

2028-03-31

Last Updated

2025-06-27

Healthy Volunteers

No

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.

Locations (12)

Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

The First Affiliated Hospital Of Soochow University

Suzhou, Jiangsu, China

Shanxi Provincial Hospital

Taiyuan, Shanxi, China

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

Xi’an, Shanxi, China

Tianjin Cancer University Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China