地塞米松联合来那度胺与硼替佐米方案治疗难治复发多发性骨髓瘤的效果

doi:10.3969/j.issn.1006-5725.2025.18.019

Abstract

Abstract:

Objective To evaluate the clinical efficacy and safety of the daratumumab-based regimens， including daratumumab， dexamethasone， and lenalidomide （DRd）， as well as daratumumab， dexamethasone， and bortezomib （DVd）， in the treatment of patients with relapsed or refractory multiple myeloma （RRMM） at our center. Methods Eighty patients with RRMM were assigned to either the DRd group （42 cases） or the DVd group （38 cases） based on their treatment regimens. Both groups received a baseline treatment of daratumumab combined with dexamethasone （Dd regimen）. In the DVd group， 1.3 mg/m² of bortezomib was administered subcutaneously on days 1， 4， 8， and 11 of each cycle， followed by a 10 day drug-free interval （days 12 ~ 21）， repeated every 3 weeks until disease progression. In the DRd group， 25 mg of lenalidomide was orally administered daily from day 1 to day 21 of each cycle， in addition to the Dd regimen， continuing until disease progression. The two groups were compared in terms of laboratory parameters， tumor markers， clinical efficacy， safety profiles， and long-term prognostic outcomes. Results After treatment， the overall response rate （ORR） of the DRd group and the DVd group was 78.57% （33 out of 42 cases） and 52.63% （20 out of 38 cases）， respectively. The serum creatinine （SCr） levels were （92.54 ± 14.33） and （102.07 ± 15.41） μmol/L， respectively； the M protein contents were （19.62 ± 2.04） and （21.08 ± 2.23） g/L， respectively； the β2-microglobulin （β2-MG） levels were （3.49 ± 1.12） and （4.16 ± 1.25） mg/L， respectively； and the progression-free survival rates were 42.86% （18 out of 42 cases） and 26.32% （10 out of 38 cases）， respectively. All these indicators showed statistically significant differences between the DRd group and the DVd group （all P < 0.05）. The incidence rates of adverse reactions in the observation group and the control group were 14.29% （6 out of 42 cases） and 13.16% （5 out of 38 cases）， respectively， and the difference was not statistically significant （P > 0.05）. Conclusion The DRd regimen demonstrates superior efficacy compared to the DVd regimen in treating patients with RRMM， leading to improved patient prognosis with a favorable safety profile.

Key words: daratumumab, lenalidomide, bortezomib, multiple myeloma, clinical efficacy, overall response rate, long-term prognostic evaluation

CLC Number:

R733.3

Yuchen ZHAO,Manting XU,Jing BAO,Liang XIA. Clinical evaluation of daratumumab in combination with lenalidomide and bortezomib and with daratumumab， bortezomib， and dexamethasone for the treatment of relapsed and refractory multiple myeloma[J]. The Journal of Practical Medicine, 2025, 41(18): 2913-2919.

Figures/Tables 5

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Tab.2

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Fig.1

References 30

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资料	DVd组（n = 38）	DRd组（n = 42）	t/χ² 值	P值
性别			0.301	0.651
男	24（63.16）	24（57.14）
女	14（36.84）	18（42.86）
年龄（x ± s）/年	61.53 ± 9.15	62.12 ± 8.29	0.304	0.762
BMI（x ± s）/（kg/m²）	22.39 ± 1.71	22.43 ± 1.72	0.175	0.862
病程（x ± s）/年	2.74 ± 2.73	2.69 ± 1.58	0.094	0.925
诊断分类			5.734	0.095
IgG型	18（47.37）	27（64.29）
IgA型	5（13.16）	7（16.66）
IgD型	0（0.00）	1（2.38）
轻链型（L + K）	15（39.47）	7（16.67）
DS分期			0.245	0.658
Ⅱ期	16（42.11）	20（45.45）
Ⅲ期	22（57.89）	22（54.55）
R-ISS分期			0.013	1.000
Ⅱ期	14（36.84）	16（38.10）
Ⅲ期	24（63.16）	26（61.90）
既往化疗周期数			0.938	0.879
5 ~ 8	17（44.74）	20（47.62）
9 ~ 12	6（15.79）	4（9.52）
13 ~ 16	8（21.05）	10（23.81）
16	4（10.53）	6（14.29）
既往复发次数			1.828	0.462
1	28（73.68）	25（59.52）
2	8（21.53）	14（33.33）
≥ 3	2（4.79）	3（7.15）
细胞遗传学风险分层			0.029	1.000
高危	17（44.74）	18（42.86）
标危	21（55.26）	24（57.14）

临床疗效	DVd组（n = 38）	DRd组（n = 42）
sCR	0（0.00）	3（7.14）
CR	2（5.26）	5（11.91）
VGPR	6（15.79）	13（30.95）
PR	6（15.79）	10（23.81）
MR	4（10.53）	1（2.38）
SD	2（5.26）	1（2.38）
PD	18（47.37）	9（21.43）
ORR	20（52.63）	33（78.57）^*

实验室指标	DVd组（n = 38）	DRd组（n = 42）
血清肌酐/（μmol/L）
治疗前	154.28 ± 24.09	155.31 ± 24.36
治疗后	102.07 ± 15.41^###	92.54 ± 14.33^###??
血尿素氮/（mmol/L）
治疗前	13.92 ± 2.38	14.01 ± 2.43
治疗后	7.69 ± 1.35^###	6.75 ± 1.12^###??
血钙/（mmol/L）
治疗前	3.05 ± 0.66	3.02 ± 0.67
治疗后	2.67 ± 0.54^###	2.42 ± 0.51^###?
球蛋白/（g/L）
治疗前	35.12 ± 2.07	34.91 ± 21.30
治疗后	27.42 ± 8.89^###	21.5 ± 9.67^###?
白蛋白/（g/L）
治疗前	36.80 ± 6.59	37.40 ± 6.47
治疗后	36.81 ± 7.09^###	37.83 ± 8.09^###?
胱抑素-C/（mg/L）
治疗前	2.53 ± 0.49	2.48 ± 0.47
治疗后	1.78 ± 0.31^###	1.64 ± 0.28^###?
血红蛋白/（g/L）
治疗前	105.65 ± 20.44	106.26 ± 21.21
治疗后	112.23 ± 17.90^###	117.48 ± 18.30^###?

肿瘤标志物	DVd组（n = 38）	DRd组（n = 42）
M蛋白含量/（g/L）
治疗前	43.87 ± 4.15	44.03 ± 4.16
治疗后	21.08 ± 2.23^###	19.62 ± 2.04^###??
β2-MG/（mg/L）
治疗前	7.49 ± 1.01	7.23 ± 1.09
治疗后	4.16 ± 1.25^###	3.49 ± 1.12^###?
LDH/（U/L）
治疗前	241.00 ± 49.22	235.00 ± 57.16
治疗后	187.46 ± 48.63^###	168.52 ± 54.11^###?
异常浆细胞/%
治疗前	24.15 ± 4.87	23.96 ± 4.53
治疗后	16.03 ± 3.25^###	13.84 ± 2.78^###??

Clinical evaluation of daratumumab in combination with lenalidomide and bortezomib and with daratumumab， bortezomib， and dexamethasone for the treatment of relapsed and refractory multiple myeloma

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