Tests SG301 with pomalidomide and dexamethasone in relapsed multiple myeloma
Tests SG301 added to standard drugs in adults with returning multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
Key facts
- Where
- Beijing, Guangzhou, Hangzhou, Luoyang, Suzhou, Taiyuan, Tianjin, Wuhan, Xi'an, and Zhengzhou, ChinaSee the 12 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06508983, who can take part
Where in China
- Beijing Chaoyang Hospital of Capital Medical UniversityBeijing, ChinaTaking people
- Guangzhou First People's HospitalGuangzhou, ChinaNot yet recruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNot yet recruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Shanxi Provincial HospitalTaiyuan, ChinaTaking people
- Tianjin Cancer University Airport HospitalTianjin, ChinaTaking people
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaNot yet recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)Xi'an, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Sumgen Biotech Co., Ltd.
- Trial code
- NCT06508983
- Record updated
- 10 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Understand and voluntarily sign the informed consent form (ICF); Males and females aged 18-75 years (inclusive); Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2; Expected survival time of ≥3 months; Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease; Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination; Subjects must have documented evidence of PD on or after the last regimen; Adequate function of vital organs; Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.
Exclusion: Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy; Previous exposure to pomalidomide; Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment; Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment; Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment; Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment; Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study; Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course; Bone independent extramedullary disease at screening; Active hepatitis B, or C; Known HIV infection; Known active tuberculosis or positive treponema pallidum antibodies; Known allergy to any component of the investigational medicinal product; Subjects with clinical significant organ dysfunction that does not meet the study needs.