Lancet Oncol: Maintenance therapy with daratumumab can significantly reduce the risk of disease progression and death in patients with multiple myeloma

The results of Part 1 of the CASSIOPEIA study showed that newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplantation (ASCT) were treated with daretuzumab, bortezomib, thalidomide, and dexamethasone (D- The depth of remission and progression-free survival of the VTd) regimen as an induction and consolidation treatment were significantly better than those of bortezomib, thalidomide, and dexamethasone (VTd) regimens
.

In the second part of the CASSIOPEIA study, the researchers compared the effect of daratumomab maintenance versus observation only on the prognosis of patients

In the second part of the CASSIOPEIA study of stem cells , the researchers compared the effect of daratumomab maintenance versus observation only on the prognosis of patients

The CASSIOPEIA study is a two-part, open-label, randomized phase 3 trial conducted at 111 locations in Europe, recruiting patients 18-65 years old with newly diagnosed ECOG performance status of 0-2 multiple myeloma
.

In Part 1, the patients were randomly (1:1) divided into two groups and received D-VTd or VTd regimen induction and consolidation therapy

Progression-free survival rate of daratumumab maintenance group and observation group

Progression-free survival rate of daratumumab maintenance group and observation group

From May 30, 2016 to June 18, 2018, a total of 886 patients (458 out of 543 in the D-VTd group and 428 out of 542 in the VTd group) were randomly assigned to daratumomab for maintenance Group (n=442) or observation group (n=444)
.

After the second randomization, the median follow-up was 35.

The median follow-up was 35.

The occurrence of adverse events

The occurrence of adverse events

The most common grade 3-4 adverse events were lymphopenia (daratumumab group vs observation group: 4% vs 2%), hypertension (3% vs 2%), and leukopenia (2% vs 2%) )
.

Serious adverse events occurred in 100 (23%) and 84 (19%) patients in the daratumumab group and observation group, respectively

Infected lymphoma

All in all, maintenance treatment with daratumomab for up to two years can significantly reduce the risk of disease progression and death in patients with multiple myeloma compared to just follow-up observation

Maintenance treatment with daratumumab for up to two years can significantly reduce the risk of disease progression and death in patients with multiple myeloma compared with follow-up observation only for up to two years.

Original source:

Philippe Moreau, et al.

Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial in this message