Daratumumab in Combination With Bortezomib and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma
Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
Newly diagnosed Multiple Myeloma patients who are ineligible for a transplant have inferior
outcomes to that of the transplant population. This is an area of high unmet need and calls
for newer therapies with novel mechanisms of action to improve survival in this
non-transplant eligible (NTE) group. Daratumumab is a monoclonal antibody that targets CD38
expressed at high levels on myeloma plasma cells. In phase 1/2 studies, it has demonstrated
impressive single agent activity in relapse and refractory myeloma with a very acceptable
toxicity profile. This set the stage for combinations with daratumumab to increase efficacy
and improve outcomes of patients in both the relapse refractory and newly diagnosed settings.
Two large Phase 2 trails using lenalidomide and dexamethasone or bortezomib and dexamethasone
along with Daratumumab demonstarted the impressive efficacy of antibody based 3 drug
combinations in the relapsed refractory myeloma setting. More recently a large clinical trial
using a Bortezomib based 4 drug combination with Daratumumab was reported from Europe in the
first-line treatment of transplant ineligible Myeloma patients showing very good survival
outcomes. Hence the investigators hypothesize that the combination of Daratumumab with
bortezomib and dexamethasone in the NTE population may therefore improve efficacy and
clinical outcomes.