multiple myeloma
Conditions
Interventions
cohort 1:selinexor: 80 mg/d QW
pomalidomide:2 mg/d,d1-21
dexamethasone: 40 mg/d,QW
cohort 2:selinexor: 60 mg/d QW
pomalidomide:4 mg/d,d1-21
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. According to the IMWG consensus diagnosis of multiple myeloma; 2. Patients with recurrent extramedullary lesions of the skin, liver, lung, central nervous system, lymph nodes or other tissues or extramedullary lesions of parabones soft tissue; 3. Age and gender are not limited; 4. Have measurable multiple myeloma, at least one of the following, or have evaluable extramedullary lesions: (1) Serum M protein (SPEP) >= 10g/L (1.0 g/dL); (2) 24-hour urine M protein level >= 0.2g (200mg); (3) Serum free light chain (sFLC) >= 100 mg/L (10 mg/dL) and abnormal free light chain ratio; 5. Male patients and women of childbearing age should be contraceptive during the study period and within 3 months after administration; 6. Females of childbearing age have negative serum or urine pregnancy test results at screening; 7. The expected survival period is more than 4 months; 8. Laboratory inspections meet the following standards: (1) Blood routine: hemoglobin (Hb) >= 60g/L; neutrophil count (ANC) >= 1.0 x 10^9/L; platelet count (PLT) >= 75 x 10^9/L; (2) Liver function: total bilirubin < 2 x upper limit of normal range (ULN); AST < 2.5 x ULN; ALT < 2.5 x ULN; Note: Supportive treatment is allowed for patients who do not meet the above conditions, and it is up to the investigator to determine whether they are suitable for inclusion; 9. Patients knew and voluntarily joined this study.
Exclusion criteria
Exclusion criteria: 1. Patients who are resistant or intolerable to the drugs in the combination regimen according to the judgment of the investigator; 2. Lactation period; 3. Patients with cardiovascular system diseases that have not been effectively controlled; 4. Active infection that has not been effectively controlled; 5. Active hepatitis infection; 6. Known allergy to drugs or excipients; 7. Active mental illness, alcohol, drug or drug abuse; 8. Patients who are judged by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Duration of relief;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactQu Xiaoyan
Jiangsu Province Hospital
Outcome results
None listed