A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06508983

Run by

Hangzhou Sumgen Biotech Co., Ltd.

People needed

360

Starts

2024-06-14

Expected to finish

2028-03-31

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Understand and voluntarily sign the informed consent form (ICF).
• Males and females aged 18-75 years (inclusive)
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
• Expected survival time of ≥3 months.
• Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.
• 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.
• Subjects must have documented evidence of PD on or after the last regimen.
• Adequate function of vital organs
• 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.

You may not qualify if…

• Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
• Bone independent extramedullary disease at screening.
• Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
• Previous exposure to pomalidomide.
• 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;
• 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;
• 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;
• Active hepatitis B, or C.
• Known HIV infection.
• Known active tuberculosis or positive treponema pallidum antibodies.
• Subjects with clinical significant organ dysfunction that does not meet the study needs.
• Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
• Known allergy to any component of the investigational medicinal product.
• 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 it is running

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

Full record on ClinicalTrials.gov

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