A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
NCT Number: NCT06508983
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Relapsed/Refractory Multiple Myeloma
Interventions: DRUG: SG301 Injection|DRUG: SG301 placebo|DRUG: pomalidomide|DRUG: dexamethasone
Sponsor: Hangzhou Sumgen Biotech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2028-03-31
Locations: Beijing Chaoyang Hospital of Capital Medical University, Beijing, Beijing, 100024, China|Guangzhou First People's Hospital, Guangzhou, Guangdong, 510000, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510000, China|First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471000, China|Henan Cancer Hospital, Zhengzhou, Henan, 450000, China|Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China|The First Affiliated Hospital Of Soochow University, Suzhou, Jiangsu, 215006, China|Shanxi Provincial Hospital, Taiyuan, Shanxi, 030000, China|The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital), Xi'an, Shanxi, 710000, China|Tianjin Cancer University Airport Hospital, Tianjin, Tianjin, 300060, China|Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, 300060, China|The Second Affiliated Hospital Zhejiang University School Of Medicine, Hangzhou, Zhejiang, 310056, China

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.

Primary Outcome Measures: Adverse events （stage 1）, AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination, From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.|Recommended stage 2 dose of SG301 (Stage 1), Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data, Up to approximately 6 months.|Progression Free Survival (Stage 2), Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone)., 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.
Secondary Outcome Measures: Pharmacokinetics (PK): AUC, The area under the curve (AUC) of serum concentration of the drug after the administration., From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.|Pharmacokinetics (PK): Cmax, Cmax to maximum drug concentration., From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.|Pharmacokinetics (PK):limination half-life (T1/2), Limination half-life (T1/2) of the drug after administration., From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.|Immunogenicity endpoints, Anti-SG301 antibody, neutralizing antibody (to be detected only in case of the presence of anti-SG301 antibody., From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.|Overall Response Rate, ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.|Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR Rate), ≥VGPR Rate (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), and very good partial response (VGPR) as best overall response., From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.|Duration of Response, Duration of response will be restricted to subjects who achieve a best objective response of PR or better., From baseline through the end of study. It is measured from the time that the criteria for objective response are first met until the date of a progression event, assessed up to approximately 4 years.|Overall Survival, Overall survival is defined as the time, in months, from randomization to the date of death from any cause., From baseline through the end of study, assessed up to approximately 4 years.|Percentage of Participants With Minimal Residual Disease (MRD), MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR or sCR, to determine the depth of response at the molecular level., From baseline through the end of study. It is measured from the time that the criteria for CR are first met until the date of a progression event, assessed up to approximately 4 years.