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

Exclusion Criteria14

• 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.