Bortezomib, Liposome Doxorubicin and Dexamethasone (PDd) Is Superior in Safety and Not Inferior in Efficiency to Bortezomib, Doxorubicin and Dexamethasone (PAd) As Induction Therapy in New-Diagnosed Multiple Myeloma Patients: An Interim Report from China's Multicenter Study

Purpose:

Bortezomib, doxorubicin and dexamethasone (PAd) and bortezomib, liposome doxorubicin and dexamethasone (PDd) are widely used as induction chemotherapy regimens in china in the new-diagnosed multiple myeloma patients before autologous stem cell transplantation or other consolidation therapy. There was no data on the comparison in safety and efficiency between that two regimens, so we design this open-label, randomized, multicenter clinical trial in China's 16 sites. Here is our interim report.

Method:

Until April 15^th 2017, 18 cases with PDd and 22 cases with PAd have finished the whole induction therapy. Incidence of adverse reaction, therapeutic effect evaluation is compared here.

Results:

There is no significant difference in age, gender, ISS stage, R-ISS stage, D-S stage between the two groups. There is also no differences in the incidence of the M-protein type between the two groups except for IgA type more often in PAd group than PDd group (7/22 vs 1/18, p=0.0537). As the 40 patients finished the 4-cycle induction therapy, effect evaluation by morphology, IFE and FLC shows no difference in sCR, CR, VGPR, PR, SD, PD, as well as in ORR. And minimal residual disease tested by flow-cytometry is also no difference between the two groups. The incidence of leukocytopenia (III-IV°) (1/18 vs 9/22, p=0.0126) and thrombocytopenia (III-IV°)(2/11 vs 11/22, p=0.0162) is lower in PDd group than in PAd group, and no difference is observed in other adverse reactions such as active infection, neutropenia, anemia, febrile neutropenia, hepatic and renal impairment, herpes, ect.

Conclusion:

There is no difference in the efficiency after 4-cycle induction chemotherapy between the PDd group and PAd group, and PDd regimen show advantages in less incidence in leukocytopenia and thrombocytopenia.