Multiple myeloma
Conditions
Interventions
Test group:DKD treatment plan
Sponsors
People‘s Hospital of Xinjiang Uygur Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 10g/L, or urinary M-protein >= 200 mg/24 hours, or in patients with undetectable serum or urinary M-protein, serum free light chain (SFLC) > 100 mg/L (for the involved light chain) with an abnormal ?/? ratio (SFLC ?/? ratio 1.65); 5. Patients who have received first-line VRd (VCD) regimen induction but did not achieve PR after 2 cycles or VGPR after 4 cycles (assessed according to the Chinese Expert Consensus on Peripheral Neuropathy in Multiple Myeloma); 6. Left ventricular ejection fraction (LVEF) = 40%, with an interventricular septum thickness of 10mm; 7. Within 14 days prior to enrollment, the patient's platelet count >= 50 × 10^9/L; hemoglobin >= 8.0 g/dL; 8. Women of childbearing age must have a negative pregnancy test prior to enrollment and agree to use contraception during the study and for 3 months after the last treatment; 9. ECOG score of 0 to 2; 10. Expected survival time >= 6 months;
Exclusion criteria
Exclusion criteria: 1. Non-active multiple myeloma with extramedullary lesions, primary amyloidosis, MGUS (monoclonal gammopathy of unknown significance), Waldenström's macroglobulinemia, POEMS syndrome, plasma cell leukemia, or smoldering myeloma; 2. Patients who have previously received other anti-tumor treatments and have a history of other malignant tumors within 3 years prior to screening (except for malignant tumors that have been cured and have a very low risk of recurrence within 3 years, such as basal cell carcinoma of the skin and the following in-situ cancers: squamous cell carcinoma, bladder carcinoma in situ, endometrial carcinoma in situ, cervical carcinoma in situ/atypical hyperplasia, incidental histologic finding of prostate cancer (TNM stage T1a or T1b), or breast carcinoma in situ); 3. Presence of 3 or more high-risk cytogenetic factors (according to NCCN 2024 V1: Del(1p32), t(4;14), t(14;16), t(14;20), del(17p)/17p monosomy/TP53 mutation, 1q21 gain/amplification, MYC translocation, high-risk gene expression profiling (GEP)); 4. Subjects with poorly controlled psychiatric disorders; 5. Subjects deemed unsuitable for participation in this trial by the investigator (any clinically significant medical condition that may affect protocol compliance or the subject's ability to provide informed consent); 6. Patients with a history of allergy to epoxyketone proteasome inhibitors; known allergies or intolerance to borates, mannitol, corticosteroids, monoclonal antibodies, or human proteins or their excipients, or known allergy to mammalian derivatives; 7. Known significant cardiac abnormalities including: a. Congestive heart failure, New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction <40% b. Uncontrolled angina, arrhythmias, or hypertension c. Myocardial infarction within the past 6 months d. Clinically significant pericardial disease or cardiac amyloidosis e. Any other uncontrolled or severe cardiovascular disease f. Symptomatic myocardial ischemia g. Poorly controlled clinically significant conduction abnormalities; 8. Female patients who are pregnant or lactating; 9. Evidence of any of the following conditions based on self-report or medical record review: a. Major surgery or severe traumatic injury within 4 weeks prior to enrollment b. Active hepatitis A, B, or C infection or known positive HBV-DNA or HCV-RNA c. Known HIV positive d. Patients with inflammatory bowel disease and other immune-related diseases e. Active infections requiring intravenous antibiotic therapy f. Other malignancies, uncontrolled infections, severe somatic diseases, or psychiatric disorders that may interfere with participation in this clinical study; major surgery within 2 weeks prior to the first dose, or incomplete recovery from earlier surgery, or planned surgery during the patient's expected participation in the study or within 2 weeks after the last dose of the study drug. Note: Patients scheduled for surgical procedures under local anesthesia may participate in the study. Kyphoplasty or vertebroplasty are not considered major surgeries; 10. Within 4 weeks prior to the first dose, have received investigational drugs (including investigational vaccines) or used invasive investigational medical devices, or are currently enrolled in an interventional investigational study; 11. Patients known or suspected to be unable to comply with the study protocol (e.g., due to alcoholism, drug dependency, or psychological disorders), o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of Very Good Partial Response (VGPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival (PFS) rate;Adverse Event(AE);>=CR rate after substitution therapy;objective response rate;>The rate of Very Good Partial Response (VGPR);MRD negativity rate; | — |
Countries
China
Contacts
Public ContactYan Li
People‘s Hospital of Xinjiang Uygur Autonomous Region
Outcome results
None listed