Comparing SG301 with standard treatment for relapsed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Chaoyang Hospital of Capital Medical University
  Beijing, Beijing Municipality, China 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

Study contacts

• Study coordinator: Jing Yang
• Email: yangjing@sumgenbio.com
• Phone: +86 010-56315401

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.