Multiple Myeloma
Conditions
Interventions
Treatment group:selinexor, carfilzomib, pomalidomide, and dexamethasone
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:18-75 years. 2. According to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revision 2022), the patient is diagnosed as multiple myeloma. 3. Imaging (CT, MRI or PET-CT) and histopathological/cytological evidence were used to diagnose extramedullary plasmacytoma. 4. Survival is expected to be longer than 6 months. 5. ECOG<=1. 6. Serum aspartate aminotransferase or alanine aminotransferase concentration should be 2.5 times or less than the upper limit of normal value, and serum total bilirubin concentration should be less than 2 times of the upper limit of normal value. 7. The platelet count of patients was = 50×10^9/L during the first 14 days before enrollment. 8. The absolute neutrophil count of patients was = 0.5 ×10^9/L during the first 14 days before enrollment. 9. Those who agree to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of allergy to selinexor, carfilzomib, pomalidomide, and dexamethasone, or any of its excipients. 2. Myocardial infarction, Grade II-IV heart failure as defined by the New York College of Cardiology (NYHA), stable and unstable angina, pericardial disease, cardiac amyloidosis, and stroke occurred within 6 months prior to enrollment. 3. Left ventricular ejection fraction (LVEF) =500ms recommended), poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mgHg), and poorly controlled diabetes (treated HBA1c) HbA1c > 8%), pulmonary embolism, or the investigator deems the subject edically unfit for participation in the study. 5. The female patient is pregnant or lactating. 6. Other malignant tumors, uncontrollable infections, serious physical or mental illness. 7. Positive for any of the following: Human immunodeficiency virus (HIV) antibodies, treponema pallidum, Treponema pallidum antibodies, hepatitis C, hepatitis C virus (HCV) antibodies, hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA positive. 8. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc., requiring long-term immunosuppressive therapy. 9. Unable to understand, follow the research protocol or sign the informed consent. 10. Women and men of childbearing age do not agree to use appropriate and effective contraceptive methods. 11. Relatives of the researcher or his/her staff. 12. Patients considered unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Overall survival, OS;Duration of Response, DOR; | — |
Countries
China
Contacts
Public ContactLuqun Wang
Qilu Hospital of Shandong University
Outcome results
None listed