Leukemia Clinical Trials

• Subjects volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;

• 18 years and older, Male and female;

• Expected survival \> 12 weeks;

• Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by Diagnosis and therapeutic criteria of hematologic disease (4th edition);

• One of the following indicators is satisfied:

‣ Serum M protein: IgG M protein ≥5 g/L; or IgA M protein ≥5 g/L; or IgD M protein and IgD \>ULN;

⁃ Urine M protein ≥200 mg/24h;

⁃ Affected serum free light chain ≥100 mg/L and Serum free light chain ratio is abnormal;

⁃ Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;

• Patients with relapsed/refractory multiple myeloma or plasma cell leukemia, satisfying:

‣ Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;

⁃ Progress is documented within 60 days of the most recent anti-tumor treatment, or efficacy assessment does not reach minimal response(MR) or above;

• Liver, kidney and cardiopulmonary functions meet the following requirements:

‣ Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL/min;

⁃ Left ventricular ejection fraction \> 50%;

⁃ Baseline peripheral oxygen saturation \> 95%;

⁃ Total bilirubin≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;

• Blood routine examination satisfying hemoglobin≥60 g/L, neutrophils≥ 1.0×10\^9/L, and platelets≥30×10\^9/L, can complete this trial according to the judgement of investigators.