Multiple myeloma
Conditions
Interventions
Treated arm:Treat with X-DTd regime
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with multiple myeloma and relapsed after frontline treatment (according to the diagnostic criteria of the International Myeloma Working Group [IMWG]); 2. Age>= 18 years old; 3. ECOG = 1.0×109/L, platelet count>= 50×109/L 5. No serious organic lesions in major organs (except renal insufficiency caused by this disease), meet the requirements of the following laboratory test indicators (performed within 7 days before treatment): 6. Total bilirubin 30ml/min. 11. Patients with measurable multiple myeloma must meet at least one of the following: 1). Serum M protein (SPEP)>= 5 g/L. 2). 24-hour urine M protein>= 0.2g (200mg). 3). Serum free light chain (sFLC)>= 100 mg/L and abnormal free light chain ratio. 4). Expected survival is greater than 6 months. 12. Female subjects of childbearing potential (FCBP) must have a negative serum pregnancy test 21 days before enrollment and agree to use effective contraception during all study medications and within 30 days after the last study medication (pregnancy testing may also be performed more frequently according to local guidelines). 13. If sexually active with FCBP, male subjects must use effective barrier contraception during the study and within 3 months after the last study medication. Male subjects cannot donate sperm during treatment and within 90 days after the last study medication. Male subjects whose partners are pregnant must abstain from sex or use contraception during vaginal intercourse. 14. Informed consent has been signed. The informed consent should be signed by the patient himself or his immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent should be signed by the legal guardian or the patient's immediate family member.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to selinexor and daratumumab. 2. Other malignant tumors other than multiple myeloma that require treatment or evidence of recurrence within 5 years prior to the first study drug (except for basal cell carcinoma of the skin and the following carcinoma in situ: squamous epithelial cell carcinoma, bladder carcinoma in situ, endometrial carcinoma in situ, cervical carcinoma in situ/dysplasia, prostate cancer with incidental histological findings (TNM stage T1a or T1b) or carcinoma in situ of the breast); 3. History of thrombosis before treatment; 4. Has any concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes mellitus, acute diffuse infiltrative lung disease) that may interfere with study procedures or results, or subjects who, in the opinion of the investigator, may pose a risk to participation in this study; 5. Major surgery within 2 weeks prior to the first dose, or not fully recovered from early surgery, or planned surgery during the subject's anticipated participation in the study or within 2 weeks after the last dose of study drug. Note: Subjects who plan to perform surgical operations under local anesthesia can participate in the study; 6. Subjects who have been treated with investigational drugs (including investigational vaccines) or used invasive investigational medical devices within 4 weeks before the first dose, or are currently enrolled in an interventional investigation and research; 7. Patients with known allergies, including but not limited to allergies/intolerances to selinexor, daratumumab, thalidomide, or dexamethasone; 8. Presence of gastrointestinal diseases that may significantly alter the absorption of oral medications; 9. Subjects who are known or suspected to be unable to comply with the study protocol (e.g., because of alcoholism, drug dependence, or psychological disorders, etc.), or who, in the opinion of the investigator, under any conditions, participation in the study is not in the best interest of the subjects (e.g., hazardous to their health), or that may hinder, limit, or confound the assessments specified in the study protocol; 10. Pregnant or lactating women; 11. Those who are considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Very good partial response;Complete remission;Partial remission;Stringent complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Progress free survival;Overall survival;Safety;The remission rate of VGPR and above evaluated by researchers; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed