PVd Versus Vd in NDMM Patients With RI

Inclusion Criteria:

• Initial diagnosis of symptomatic multiple myeloma (according to the InternationalMyeloma Working Group [IMWG] diagnostic criteria)
• Men and women aged ≥18 years and ≤75 years
• Multiple myeloma patients with measurable M protein should meet at least one of thefollowing three tests: 1) Serum M protein ≥10 g/L; 2) Urinary M protein ≥200 mg/24h;

3. In the case of abnormal serum free light chain ratio, the level of affected freelight chain ≥100 mg/L

• No prior treatment for multiple myeloma
• ECOG score ≤2, and predicted survival ≥3 months
• Clinically diagnosed multiple myeloma-related renal injury with calculated or measuredcreatinine clearance (CrCl)≥15 mL/min and < 60 mL/min (excluding patients undergoingdialysis). The calculated CrCl should be calculated using the widely accepted formula (i.e. Cockcroft-gault formula) :([140-Age] × body weight [kg] / [72 × creatininemg/dL]); If the subject is female, multiply the result by 0.85 (1mg/dL=88.4umol/L)
• Hematology: When myeloma cells < 50%, ANC≥1.0×109/L (including with g-CSF support) andPLT≥75×109/L; Myeloma cells ≥50%, any ANC and PLT≥30×109/L; Adjusted serum calciumlevel ≤3.4 mmol/L; Hemoglobin level ≥8 g/dL
• For the use of symptomatic and supportive therapy only, the biochemical requirementsof 6 and 7 achieved by non-myeloma treatment drugs can also be included in the group
• Liver, heart and other major organs meet the requirements of the following laboratoryexamination indicators (conducted within 7 days before treatment): 1) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) Aspartate aminotransferase (AST) and alanine transferine (ALT) ≤ 1.5 times the upper limit of normal value (sameage); 3) myocardial enzymes < 2 times the upper limit of normal value; 4)Echocardiography (ECHO) determined that cardiac ejection fraction was within thenormal range.
• Patients with inactive hepatitis and total bilirubin, AST and ALT meeting theinclusion criteria, but HBV-DNA≥104, are recommended to be treated with entecavir andother antiviral drugs, and the treatment course will be determined by researchersafter their own evaluation of the patient's situation
• Women of reproductive age (FCBP) subjects must have a negative serum pregnancy test 21days prior to enrollment and consent to use a valid contraceptive method during allstudy medications and within 30 days after the last study medication (pregnancy testsmay be performed more frequently if local guidelines are followed). FCBP is defined inthis protocol as sexually mature women who: 1) have not undergone hysterectomy,bilateral oophorectomy or bilateral salpingectomy, or 2) have not experiencedspontaneous menopause for at least 24 consecutive months (i.e., have had menstruationat any time in the previous 24 consecutive months)
• If having sex with FCBP, male subjects must use an effective barrier method ofcontraception during the study period and for 3 months after the last study drug. Malesubjects were not allowed to donate sperm during treatment and for 90 days after thelast study drug. Male subjects whose partners are pregnant must abstain from sex oruse condoms during vaginal intercourse
• Clearly understand the test content, voluntarily participate in and complete the test,and sign the informed consent. Informed consent was signed by the patient himself orhis immediate family. Considering the patient's condition, if the patient's signatureis not conducive to treatment, the informed consent shall be signed by the legalguardian or the patient's immediate family member
• Those who can receive and use antithrombotic drugs, such as low-molecular-weightheparin sodium or aspirin, etc.

Exclusion Criteria:

• Primary renal disease or secondary renal injury not related to multiple myeloma, suchas diabetes
• Prior treatment for myeloma (excluding radiation, bisphosphonates, or a singleshort-term hormone therapy [i.e., a 4-day dose less than or equivalent todexamethasone 40mg/ day])
• Non-active multiple myeloma, including MGUS and smoking myeloma
• Prior malignancies requiring treatment or with evidence of recurrence in the 5 yearsprior to the first study [excluding basal cell carcinoma of the skin and the followingcarcinomas in situ: Squamous cell carcinoma, carcinoma in situ of bladder, carcinomain situ of endometrium, carcinoma in situ of cervix/dysplasia, occasional histologicaldiscovery of prostate cancer (TNM stage T1a or T1b) or carcinoma in situ of breast]
• Patients with renal insufficiency accompanied by dialysis (excluding those who hadreceived dialysis treatment due to renal insufficiency in the early stage but had notreceived anti-MM treatment and were not on dialysis at the time of enrollment)
• Active hepatitis A, B, C infection or known HCV RNA positive
• Known to be HIV positive
• Active infections that are not under control
• History of VTE or cerebral infarction before treatment
• Patients had uncontrolled or severe cardiovascular disease, including myocardialinfarction within 6 months prior to enrollment, NYHA defined class ⅲ - ⅳ heartfailure, uncontrolled angina, congestive heart failure, clinically significantpericardial disease, or cardiac amyloidosis (NT-Pro-BNP≥1800pg/mL)
• Patients who received major operations within 30 days before the enrollment, whichwould cause significant physical decline and increased risk of thrombosis, or theoperations were scheduled during the study period. Participants who planned to undergosurgery under local anesthesia that would not significantly affect the patient'sphysical performance or significantly increase the risk of thrombosis couldparticipate in the study
• The proportion of peripheral plasma cells ≥5%, and/or the absolute value of peripheralplasma cells ≥0.5×109/L
• Subjects are pregnant or lactating women
• Uncontrolled high blood pressure or uncontrolled diabetes
• Allergic to borate, mannose, and thalidomide
• According to the protocol or the investigator's judgment, the patient's seriousphysical or mental illness may interfere with the clinical study participation;Substance abuse, medical, psychological, or social conditions that may interfere withsubjects' participation in the study or evaluation of study results
• Patients receiving other experimental drugs
• Participants in other clinical trials within one month
• Any patients deemed unsuitable for inclusion by other investigators