Multiple Myeloma
Conditions
Interventions
Four:Different doses of HG146 Capsule
Sponsors
West China Hospital, Sichuan Universty
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG]); 3. Patients must have 2 prior lines of treatment including proteasome inhibitors and immunomodulators; 4. Measureable disease, as defined by at least one of the following: serum M protein 10 g/L or higher, urine M protein 200 mg/24 hour or higher; 5. Patients are not suitable for autologous bone marrow transplantation or refuse autologous bone marrow transplantation or relapse after autologous bone marrow transplantation; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2; 7. The level of organ function must meet the following requirements: Bone marrow function: The absolute number of neutrophils(ANC)=1.0*10^9/L; Hemoglobin(HGB)=8g/dL (80g/L); Platelet(PLT)=75,000/µL; Renal function: Creatinine clearance rate>30mL/min; Hepatic function: Bilirubin in serum<1.5*ULN(2.0mg/dL/20mg/L/34.2µmol/L); ALT and/or AST=3*ULN (upper limit of normal); Cardiac function: Normal electrocardiogram, echocardiography and myocardial enzyme spectrum; 8. Calibration of blood calcium concentration=ULN; 9. Non-pregnant women and men and women who did not consider giving birth during the trial or five years after the end of the trial; 10. The patient is able to swallow the capsule; 11. Patients must provide written consent.
Exclusion criteria
Exclusion criteria: 1. Severe allergies to the study drug or any of its exciptients; 2. The following subjects should be excluded due to the possibility of gene toxicity, mutagenesis and teratogenicity: Men and women who did not have sperm or egg cells stored in vitro before the trial and who planned to have children again within five years. Pregnant or lactating women; 3. Treatment status of subjects before trial: Autologous bone marrow transplantation was performed 3 months before admission. Received allogeneic bone marrow transplantation. HDAC inhibitors have been used before. Two weeks prior to admission, received radiotherapy or bone marrow suppressive chemotherapy or biological treatment. 4. Patients with history of other malignant tumors, except the tumor is in remission and has not been treated for at least 5 years; 5. Patients with dysphagia or oral absorption disorder; 6. The investigators determine the conditions not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| M protein;immune fixation electrophoresis;blood and urinary light-chain;blood routine; | — |
Countries
China
Contacts
Public ContactLiu ting
West China Hospital, Sichuan University
Outcome results
None listed