A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
NCT ID: NCT06508983
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2024-06-14
2028-03-31
Brief Summary
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Detailed Description
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This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Stage 1 ：Single group. Subjects will receive SG301 Injection in combination with pomalidomide and dexamethasone.
Stage 2：Parallel. Subjects will be randomized to receive SG301 Injection in combination with pomalidomide and dexamethasone or placebo in combination with pomalidomide and dexamethasone.
TREATMENT
QUADRUPLE
Study Groups
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SG301 Injection in combination with pomalidomide and dexamethasone
Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
SG301 Injection
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.
Placebo in combination with pomalidomide and dexamethasone
Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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 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 Criteria
2. Bone independent extramedullary disease at screening.
3. Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
4. Previous exposure to pomalidomide.
5. 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;
6. 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;
7. 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;
8. Active hepatitis B, or C.
9. Known HIV infection.
10. Known active tuberculosis or positive treponema pallidum antibodies.
11. Subjects with clinical significant organ dysfunction that does not meet the study needs.
12. Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
13. Known allergy to any component of the investigational medicinal product.
14. 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.
18 Years
75 Years
ALL
No
Sponsors
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Hangzhou Sumgen Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China
Shanxi Provincial Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, China
Tianjin Cancer University Airport Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Wenming Chen, Doctor
Role: primary
Ying Tian
Role: backup
Shunqing Wang
Role: primary
Wei Zhou
Role: backup
Zhongjun Xia
Role: primary
Xiaoqin Chen
Role: backup
Haiping Yang
Role: primary
Bingke Zhu
Role: backup
Baijun Fang
Role: primary
Yuzhang Liu
Role: backup
Chunyan Sun
Role: primary
Fei Zhao
Role: backup
ZhengZheng Fu
Role: primary
Yingying Zhai
Role: backup
Liping Su
Role: primary
Jingrong Wang
Role: backup
Wanhong Zhao
Role: primary
Fangxia Wang
Role: backup
Yafei Wang
Role: primary
Zhiying Zhang
Role: backup
Yafei Wang
Role: primary
Haifeng Zhao
Role: backup
Wenbin Qian
Role: primary
Xuzhao Zhang
Role: backup
Other Identifiers
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CSG-301-301
Identifier Type: -
Identifier Source: org_study_id
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