Multiple Myeloma (MM)
Conditions
Interventions
Experimental group:selinexor, bendamustine, bortezomib, and dexamethasone
Sponsors
Chongqing Xinqiao Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years. 2. Meet the diagnostic criteria for multiple myeloma and have measurable extramedullary lesions. 3. ECOG score 6 months. 5. Functional reserve of vital organs shall meet the following requirements: (1) Hematopoietic function: 1) Absolute value of neutrophil count (ANC) >=1.0x10^9/L (>=0.5x10^9/L for patients with bone marrow infiltration) (G-CSF was not used within 1 week before blood routine examination in screening period, and long-acting up-white needle was not used within 2 weeks); 2) Platelet count >=75x10^9/L (>=50x10^9/L for patients with bone marrow infiltration) (no platelet infusion or TPO agonist was used within 1 week before routine blood examination during screening period); 3) Hemoglobin >=90 g/L (>=70 g/L for patients with bone marrow infiltration) (no red blood cells were transfused and no EPO was used within 1 week before routine blood examination during screening period). (2) Liver function: serum total bilirubin <=1.5xULN (Gilbert's syndrome <=3 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5xULN, ALT/AST<=5xULN in patients with liver infiltration, alkaline phosphatase <=5xULN in patients with liver and/or bone infiltration. 6. Fertile patients must ensure that reliable contraceptive methods are used between the time before enrollment and three months after the last medication. Female patients did not donate eggs for assisted reproduction purposes during the study period and within 3 months after receiving the last dose. 7. In fertile female patients, serum or urinary HCG tests were negative for 14 days prior to initial dosing. 8. The patient or his legal representative will voluntarily sign an informed consent form indicating that he understands the mother and procedure of the study and agrees to participate in the study. 9. Patients must be willing and able to abide by the contraindications or restrictions set forth in this study protocol.
Exclusion criteria
Exclusion criteria: 1. Received prior treatment with selinexor or other nuclear export protein inhibitors. 2. Uncontrolled systemic infection. 3. The subject has uncontrolled heart disease, including: myocardial infarction within 6 months before starting the drug, or unstable disease related to cardiac function that can affect the cardiac function (unstable angina, congestive heart failure, New York Heart Association new functional class III-IV). Uncontrolled arrhythmia (grade 2 or higher as defined by the latest version of CTCAE), or clinically significant ECG abnormalities. Screening electrocardiogram showed a QT interval >470 ms. 4. HBsAg positive; or HBsAg negative, but HBcAb positive and the HBV-DNA copy number higher than the upper limit of the normal limit of the detection value; HCV antibody positive, and the HCV-RNA copy number higher than the normal upper limit of the detection value. 5. There is a history of vaccination within 3 months before the first administration of this trial. 6. Subjects who are known to be allergic to the study drug or its active ingredients and excipients. 7. Subjects who have undergone major surgery within 4 weeks before the start of study treatment or are planning to undergo major surgery during the study period (except for surgery such as puncture or lymph node biopsy) 8. Subjects unable to swallow, or active gastrointestinal bleeding, inflammation, chronic diarrhea, known diverticulosis, or history of previous gastrectomy or gastric banding that affects drug absorption. 9. Those with a history of psychotropic substance abuse or drug addiction. 10. Those who may not be able to complete the study for other reasons or who the researcher considers should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;time to remission;progression-free survival; | — |
Countries
China
Contacts
Public ContactZeng Yunjing
Chongqing Xinqiao Hospital
Outcome results
None listed