A Study of HG146 Capsule in Chinese Subjects with Relapsed and Refractory Multiple Myeloma

Inclusion Criteria

• •Diagnosis of multiple myeloma requiring systemic therapy (International Myeloma Working Group \[IMWG\]) and 2 cycles of treatment including proteasome inhibitors and/or immunomodulators.
• •Serum M protein≥ 10.0g / L, or urine M protein ≥ 200mg / 24h.
• •Not suitable for autologous bone marrow transplantation or refuse autologous bone marrow transplantation or relapse after autologous bone marrow transplantation.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
• •Expected survival of ≥3 months.
• •Hemoglobin ≥ 80 g/L, Platelet≥75×10\^9/L, Absolute Neutrophil Count≧1.0×109/L (1000 cells/mm3), Prothrombin time(PT) and activated partial thromboplastin time ≤ 2 x Upper Limit of Normal (ULN).
• •Bilirubin in serum\<1.5\*ULN (2.0mg/dL/20mg/L/34.2μmol/L); glutamic-pyruvic transaminase (ALT) and/or Aspartate Aminotransferase (AST)≤3\*ULN (upper limit of normal).
• •Normal electrocardiogram, echocardiography and myocardial enzyme spectrumCalibration of blood calcium concentration≤ULN.
• •Men and women, Non-pregnant women who did not consider giving birth during the trial or five years after the end of the trial.
• •The patient is able to swallow the capsule.
• •Patients must provide written consent.