Multiple myeloma
Conditions
Interventions
B0 queue:purinostat mesylate for injection(PM):ntravenous infusion of 3.0mg/m2 was administered on days 1, 4, 15, and 18 of each cycle, and 4 weeks (28 days) was a cycle regimen
pomalidomide capsules:Orally, 4mg/ time, once a day, for 21 consecutive days, stop for 7 days, 4 weeks (28 days) as a cycle regimen
Dexamethasone acetate tablet (DEX):Orally, 20mg/day, Dosing was performed on days 1, 2, 8, 9, 15, and 16 of each cycle, 4 weeks (28 days) as a cycle regimen.
B1 queue:purinostat mesylate for injection(PM):ntravenous infusion of 4.0mg/m2 was administered on days 1, 4, 15, and 18 of each cycle, and 4 weeks (28 days) was a cycle regimen
B2 queue:purinostat mesylate for injection(PM):ntravenous infusion of 6.0mg/m2 was administered on days 1, 4, 15, and 18 of each cycle, and 4 weeks (28 days) was a cycle regimen
B3 queue:purinostat mesylate for injection(PM):ntravenous infusion of 8.4mg/m2 was administered on days 1, 4, 15, and 18 of each cycle, and 4 weeks (28 days) was a cycle regimen
Dexamethasone acetate tablet (DEX):Orally, 20mg/day, Dosing was performed on d
Sponsors
West China Hospital of Sichuan University/Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of multiple myeloma (MM) with reference to the diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (Revised in 2022); 2. Those who have received at least one line of systemic anti-myeloma therapy in the past (including lenalidomide and proteasome inhibitors, see Appendix 4 for the count of myeloma treatment lines), and meet the definition of relapsed or refractory; Definition of recurrence: disease progression that occurs at least 60 days after the last treatment (except for those who have relapsed more than 1 year after treatment) with an evaluation of the efficacy of previous treatment regimens of MR or better; Refractory definition: progression during prior treatment or progression within 60 days after the last treatment; or have not reached MR or above after at least 2 courses of treatment; or treatment intolerance. 3. Age 18-75 years old, male or female, if the subject is of childbearing age, should use effective contraceptive measures, must agree to comply with all contraceptive requirements: 1) Women of childbearing potential must agree to and comply with the contraceptive measures specified in the protocol: starting from 4 weeks before the use of this product, during the treatment period, during the dose suspension period and within 4 weeks after the termination of treatment, two reliable contraceptive methods (one highly effective contraceptive method - tubal ligation, intrauterine device, hormones (contraceptive pills, needles, patches, vaginal rings or implants) or partner vasectomy, and another effective contraceptive method - rubber or synthetic condoms, diaphragms or cervical caps for men. Effective contraception is required even if there is a history of infertility unless due to hysterectomy; 2) Men of childbearing potential must continue to use rubber or synthetic condoms during sexual contact with women of childbearing potential during treatment, during dose suspension and within 4 weeks after treatment termination from 4 weeks before treatment with this product, even if they have successfully undergone vasectomy; 4. Multiple myeloma subjects with measurable M protein, i.e., at least one of the following 3 assays: 1) Serum M protein>=0.5g/dL (5g/L); 2) urine M protein>=200mg/24h; 3) Serum free light chain determination: in the case of abnormal serum free light chain ratio (less than 0.26 or greater than 1.65), the level of involved free light chain >=10mg/dL (100mg/L); 5. Hematology meets the following conditions: 1) ANC>=1×10^9/L (granulocyte colony-stimulating factor was not used within 7 days), when the plasma cells in the bone marrow were = 50%, the neutrophil count was not specifically required; 2) PLT>=75×10^9/L (no platelet transfusion or thrombopoietin within 7 days), when plasma cells in the bone marrow 1. Refer to the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (Revised in 2022)" to diagnose multiple myeloma (MM); 2. Those who have received at least one line of systemic anti-myeloma therapy in the past (including lenalidomide and proteasome inhibitors, see Appendix 4 for the count of myeloma treatment lines), and meet the definition of relapsed or refractory; Definition of recurrence: disease progression that occurs at least 60 days after the last treatment (except for those who have relapsed more than 1 year after treatment) with an evaluation of the efficacy of previous treatment regimens of MR
Exclusion criteria
Exclusion criteria: 1. Those who have previously used histone deacetaminase (HDAC) inhibitors (except chidamide), antibody-conjugated degraders (DACs), HSP90 inhibitors or valproic acid for anti-tumor therapy; or according to the judgment of the investigator, those who cannot tolerate HDAC inhibitors, pomalidomide, thalidomide, lenalidomide and other similar types of drug treatment (such as >=grade 3 rash, severe refractory myelosuppression, etc.) during previous medication; 2. Those who have progressed on disease after receiving standard dose pomalidomide treatment in the past; 3. Those who have had an allergic reaction to the ingredients contained in the test drugs involved in this test; 4. Diagnosed with non-secretory MM (refers to subjects who do not secrete at all or have a small amount of free light chains but the involved light chains are less than 100mg/L), or MM with amyloidosis, or those who have primary or plasma cell leukemia during treatment; 5. Those with active new thrombosis or unable to receive antithrombotic therapy; 6. Other malignant tumors within 5 years prior to screening, except for treated carcinoma in situ (such as cervix, breast, bladder, etc.), basal cell carcinoma of the skin, squamous cell carcinoma of the skin or early prostate cancer (clinical stage Tla or T1b); 7. Those with central nervous system diseases and need to be treated; 8. Peripheral neuropathy >=grade 3; 9. Patients with comorbid diseases that require long-term treatment with immunosuppressants or steroids; 10. Those with active infectious diseases, including the following: 1) Positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb), and HBV-DNA quantification is higher than the upper limit of normal; 2) Hepatitis C virus antibody (HCV-Ab) was positive, and HCVRNA quantification was higher than the upper limit of normal; 3) Those who are positive for human immunodeficiency virus antibody (HIV-Ab) or anti-treponemal antibody (TP-Ab); 11. Subject has any of the following: 1) Cardiac insufficiency > = grade 3 according to NYHA grading (Appendix 1) criteria; 2) myocardial infarction within 6 months; 3) poorly controlled angina within 6 months, including variant angina; 12. Those with severe infectious diseases 2 weeks before the first dose and require systemic intravenous antibiotic therapy; 13. Those who have received allogeneic hematopoietic stem cell transplantation within 12 months, or those who have active graft-versus-host response disease (GVHD) or GVHD for more than 12 months after allogeneic hematopoietic stem cell transplantation and need to receive immunosuppressive therapy; 14. Those who have participated in other clinical trials within 4 weeks before the first dose; 15. Those who have received other anti-tumor therapy within 2 weeks before the first dose (including traditional Chinese medicine anti-tumor therapy, except for <=20mg/day of prednisone and its equivalent dose of steroid hormones); 16. Those who have not recovered to Grade 1 or below from the toxicity of previous anti-tumor therapy (except for alopecia, fatigue and the content specified in Article 6 of the inclusion criteria); 17. Those who have received major surgical treatment within 4 weeks before the first dose and have not fully recovered; 18. Women who are pregnant or breastfeeding; 19. Those who believe that the investigator has other factors that are not suitable for participating in the trial (such as uncontrolled active hypertension, uncontrolled active diabe
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (investigator assessment);Duration of Response;Time to remission;Progression free survival;Overall survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate (IRC assessment); | — |
Countries
China
Contacts
Public ContactTing Niu, Lu Jin
West China Hospital of Sichuan University/Peking University People's Hospital
Outcome results
None listed