Actively Recruiting
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
Led by Hangzhou Sumgen Biotech Co., Ltd. · Updated on 2025-06-27
360
Participants Needed
12
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form
- Males and females aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Expected survival time of at least 3 months
- Documented diagnosis of multiple myeloma with measurable disease
- Received at least 1 prior anti-myeloma therapy including lenalidomide and a proteasome inhibitor
- Documented evidence of disease progression on or after the last treatment regimen
- Adequate function of vital organs
- Women of childbearing potential must agree to contraception and have 2 negative pregnancy tests before starting treatment
You will not qualify if you...
- Primary refractory multiple myeloma (no minimal response to any treatment)
- Bone independent extramedullary disease at screening
- Primary refractory to prior CD38 monoclonal antibody therapy
- Previous exposure to pomalidomide
- Chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives before first study dose
- Tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives before first study dose
- Investigational agents within 4 weeks or 5 pharmacokinetic half-lives (minimum 14 days) before first study dose
- Active hepatitis B or C
- Known HIV infection
- Active tuberculosis or positive treponema pallidum antibodies
- Significant organ dysfunction not meeting study requirements
- Previous allogenic or autologous stem cell transplant before first study dose
- Known allergy to study drug components
- Any medical or psychiatric condition that might interfere with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100024
Actively Recruiting
2
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
7
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
8
Shanxi Provincial Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
9
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, China, 710000
Actively Recruiting
10
Tianjin Cancer University Airport Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
11
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
12
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China, 310056
Actively Recruiting
Research Team
J
Jing Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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