This study is a prospective, single center, single arm phase II clinical trial. The study population consists of patients who have received treatment with VRd or VRd lite regimens for 2-8 courses in the past and have achieved therapeutic effects, but have progressed during treatment (primary refractory), experienced clinical recurrence for the first time after treatment, or progressed or recurred after the first transplant (without entering maintenance therapy). 72 patients are planned to be enrolled and receive 4 courses of induction therapy with D-KPd regimen for the first efficacy evaluation. For patients with ≥ SD, if the patient has ≥ PR and is suitable for ASCT, ASCT treatment will be given. For patients with\<PR or not suitable for ASCT, 4 courses of consolidation therapy with D-KPd regimen will be continued for the second efficacy evaluation SD patients continue to receive 4 courses of D-KPd regimen consolidation treatment. D-KPd dosing regimen: Daratumumab: 16mg/Kg, IV or 1800mg Sc; C1-2 d1,8,15,22; C3-6 d1,15; C7-12 d1。 Cafizomide: 20mg/m2; C1-8 d1,2,8,9,15,16； C9-12 d1,2,15,16； After tolerance to 20mg/m2, the dose of C1D1 and C1D2 can be adjusted to 27g/m2. Pomalidomide: 4mg, PO,d1-21。 Dexamethasone: 20mg, po,d1, 2,8,9,15,16,22,23. If the age is over 75 years old, the Dex dose is halved. The main efficacy endpoint after 12 treatment courses is: ORR； Secondary efficacy endpoint indicators: mPFS, mOS, ≥ VGPR rate, MRD negative rate, safety
Men and women aged ≥ 18 years old;
Functional high-risk patients: Patients who have previously received treatment with VRd or VRd lite regimens for 2-8 courses and achieved therapeutic effects, but have progressed during treatment (primary refractory), experienced clinical recurrence for the first time after treatment, or developed progression or recurrence after the first transplantation (not entered maintenance treatment).
Multiple myeloma patients with measurable M protein must meet at least one of the following three criteria: 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 affected free light chain level is ≥ 100 mg/L [18];
Physical condition (ECOG) score 0-2 points, expected survival period ≥ 3 months;
Non active multiple myeloma, including MGUS and smoking myeloma;
Subjects with POEMS syndrome or known/suspected amyloidosis in any organ;
Subjects with plasma cell leukemia: patients with a proportion of peripheral plasma cells ≥ 5% and/or an absolute value of peripheral plasma cells ≥ 0.5 × 109/L;
Patients who have been exposed to daratumumab in the past;
Single group
Daratumumab
DrugDaratumumab: 16mg/Kg, IV or 1800mg Sc; C1-2 d1,8,15,22; C3-6 d1,15; C7-12 d1
Cafizomide
DrugCafizomide: 20mg/m2; C1-8 d1,2,8,9,15,16； C9-12 d1,2,15,16；After tolerance to 20mg/m2, the dose of C1D1 and C1D2 can be adjusted to 27g/m2.
Pomalidomide
DrugPomalidomide: 4mg, PO,d1-21
Dexamethasone
DrugDexamethasone: 20mg, po,d1, 2,8,9,15,16,22,23.
ORR
the rate of very good partial response or better
OS
overall survival
PFS
Progression-free survival
MRD negative rate
the rate of minimal residual disease negativity
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