Comparing SG301 with standard treatment for relapsed multiple myeloma

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

This study is testing if adding a new injection called SG301 to standard treatments can help people with relapsed multiple myeloma feel better and have better results.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 12 sites (Beijing, Beijing Municipality and 11 other locations)
• Trial ID: NCT06508983 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of SG301 injection when added to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. It is a randomized, placebo-controlled, double-blind phase III trial that includes two stages: an initial dose exploration stage followed by a randomized controlled stage. Participants must have previously received at least one treatment regimen that included lenalidomide and a proteasome inhibitor, and must show disease progression. The study aims to determine if the addition of SG301 improves treatment outcomes compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with relapsed or refractory multiple myeloma who have previously received specific anti-myeloma therapies.

Not a fit: Patients who have not received prior treatment with lenalidomide and a proteasome inhibitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating multiple myeloma, indicating potential for success.

Eligibility criteria

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 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:

1. Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
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.

Where this trial is running

Beijing, Beijing Municipality and 11 other locations

• Beijing Chaoyang Hospital of Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The First Affiliated Hospital Of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Shanxi Provincial Hospital — Taiyuan, Shanxi, China (Recruiting)
• The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital) — Xi’an, Shanxi, China (Recruiting)
• Tianjin Cancer University Airport Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School Of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jing Yang

Conditions Relapsed/Refractory Multiple Myeloma