A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomal
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.
| Condition(s) | Relapsed/Refractory Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form (ICF). 2. Males and females aged 18-75 years (inclusive) 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2 4. Expected survival time of ≥3 months. 5. Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease. 6. 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. 7. Subjects must have documented evidence of PD on or after the last regimen. 8. Adequate function of vital organs 9. Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before th |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Hangzhou Sumgen Biotech Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Luoyang, Henan, China; Zhengzhou, Henan, China; Wuhan, Hubei, China (+6 more sites) |
| Start date | 2024-06-14 |
| NCT ID | NCT06508983 |
| Official listing | https://clinicaltrials.gov/study/NCT06508983 |