Aim To analyze the efficacy and safety of Ixazomib, pomalidomide and dexamethasone (IxaPD) regimen in patients with refractory and relapsed multiple myeloma(RRMM).

Methods Clinical data of RRMM patients were prospectively collected from 5 centers in north China from Mar 2021 to Nov 2023 who were treated by IxaPD regimen for at least two courses. Overall response rate (ORR), time to next treatment (TTNT) and overall survival (OS) were analyzed as end points.

Results A total of 50 patients were enrolled, including 30 in multicenter real-world study and 20 in investigator initiated IxaPD trial (NCT04989140) who were naïve to ixazomib or pomalidomide with previous treatment of 1 to 3 lines. There were 28 males and 22 females with the median age 65.5 (range 41-82) years old. The median duration from diagnosis to enrollment was 30 months (range 1-170), including 26/50 (52.0%) patients were in first relapse. Twenty-three in 41 (56.1%) patients had high-risk cytogenetic abnormalities. Regarding previous history, 15.2% presented renal insufficiency, 4 cases (8.0%) had extramedullary diseases, and 7 case (14.0%) received autologous hematopoietic stem cell transplantation (ASCT). After median 8.5 courses (range 2-23) of IxaPD regimen, the ORR was 70.0%, with 54.0% VGPR or better. The median time to achieve the best response was 2 months (range 1-9). After a median follow-up of 18 months (range 3-47), 62.0% of patients progressed and the median TTNT was 9.5 months (range 2-31). The mortality rate was 24.0%, and the median OS was not reached. In the multivariate analysis, age, first relapse, R-ISS, high-risk cytogenetics abnormalities, and renal insufficiency and response to first-line induction therapy did not significantly affect TTNT. Neither did those factors also have significant impact on OS. Most of the adverse effects (AEs) were grade 1-2, mainly skin rash, peripheral neuropathy, constipation, diarrhea, edema, arthralgia, herpes zoster, and shortness of breath. There were only two grade 3 AEs, one for pulmonary infection and one for severe myelosuppression.

Conclusion The pan-oral IxaPD regimen showed anticipated effect and good tolerance for RRMM patients. More patients are being enrolled and update data will be reported.

【Key words】 Multiple myeloma; refractory and relapse; pan-oral regimen; ixazomib; pomalidomide

Disclosures

No relevant conflicts of interest to declare.

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