Multiple myeloma
Conditions
Interventions
Trial group:Selinexor combined conditioning regimen and maintenance therapy
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 77 Years
Inclusion criteria
Inclusion criteria: 1. Clinically confirmed multiple myeloma combined with renal insufficiency or elderly patients and patients with high-risk or refractory/early recurrence of multiple myeloma (R/R MM); 2. Age: 18-77 years old; 3. Achievement of CR or PR/VGPR after induction chemotherapy; 4. Those who do not have serious functional impairment of important organs of the whole body; 5. No history of drug allergy in the protocol; 6. Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after the study lasts for six months; If the subject is pregnant or suspects pregnancy, the investigator should be notified immediately; 7. Subject understands and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Aged 70 years; 2.ECOG performance status score = 3; 3.NYHA functional class III or IV; 4.There are basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, severe renal dysfunction, gastrointestinal insufficiency, etc; 5.Clinically uncontrolled active infection; 6.Currently participating in other clinical trials or planning to start this study within less than 4 weeks after the completion of the previous clinical trial; 7.Presence of other malignant tumors requiring treatment; 8.History of allergy to the study drugs; 9.Female participants who are pregnant or breastfeeding; 10.Human immunodeficiency virus (HIV) infection or syphilis infection; 11.Active hepatitis that remains uncontrolled despite aggressive antiviral therapy (positive HBV DNA or HCV RNA tests); 12.Patients with persistent positive COVID-19 tests (excluding those who have turned negative); 13.Any condition that the investigator believes may increase the risk to the participant or interfere with the study results;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Renal function improvement rate;MRD negative rate;Safety; | — |
Countries
China
Contacts
Public ContactDonghua Zhang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed