A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
SG301 Injection: Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
SG301 placebo: Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
pomalidomide: Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Adverse events (stage 1) — From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination - Recommended stage 2 dose of SG301 (Stage 1) — Up to approximately 6 months.
Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data - Progression Free Survival (Stage 2) — From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.
Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Chaoyang Hospital of Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Not Yet Recruiting |
| First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| The First Affiliated Hospital Of Soochow University | Suzhou | Jiangsu | Recruiting |
| Shanxi Provincial Hospital | Taiyuan | Shanxi | Recruiting |
| The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital) | Xi’an | Shanxi | Recruiting |
| Tianjin Cancer University Airport Hospital | Tianjin | Tianjin Municipality | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| The Second Affiliated Hospital Zhejiang University School Of Medicine | Hangzhou | Zhejiang | Recruiting |
More Hangzhou Sumgen Biotech Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06508983 on ClinicalTrials.gov ↗ ← All trials in China