To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma
Bone marrow cytology, bone marrow biopsy tissue, or flow cytometry showing ≥5% clonal plasma cells or immature plasma cells;
Serum M-protein levels: IgG type M-protein ≥10 g/L; or IgA, IgD, IgE, IgM type M-protein ≥5 g/L;
24-hour urine M-protein level ≥200 mg;
For light chain multiple myeloma without measurable serum or urine lesions: serum free light chain (sFLC) ≥100 mg/L and abnormal serum κ/λ free light chain ratio;
QTc interval >470 ms (QTc interval corrected using the Fridericia formula);
New York Heart Association (NYHA) Class II or higher heart failure;
Unstable angina or acute myocardial infarction within 6 months prior to signing the informed consent form (ICF);
Left ventricular ejection fraction (LVEF) <50%;
Hebei Senlang Biotechnology Inc., Ltd.
Lead sponsor
Peking University People's Hospital
Collaborator
Institute of Hematology & Blood Diseases Hospital, China
Collaborator