Role of bortezomib maintenance therapy in the anti-CD38 antibody era: Interim analysis results of a randomized Phase III study for transplant-ineligible newly diagnosed multiple myeloma (JCOG1911/B-DASH Study)
Randomized trial reveals no improvement in progression-free survival with bortezomib maintenance in transplant-ineligible patients, indicating tolerability issues.
Key Points
This research aims to evaluate the efficacy of adding bortezomib to Daratumumab maintenance therapy for transplant-ineligible newly diagnosed multiple myeloma.
Randomized phase III study involving patients with newly diagnosed multiple myeloma who are transplant-ineligible.
Patients received Daratumumab and bortezomib as maintenance therapy over 24 cycles after induction therapy.
Primary endpoint: progression-free survival after the second registration; interim analysis conducted after 20 PFS events.
Interim analysis showed 2-year progression-free survival rates of 80.2% for Daratumumab alone and 72.5% for the combination with bortezomib.
Bortezomib did not improve progression-free survival compared to Daratumumab alone, with significant adverse events leading to treatment discontinuation in arm B.
Median follow-up was 1.3 years, revealing serious tolerability issues related to bortezomib.