Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA)
Status:
Unknown status
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
Summary
This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with
newly diagnosed Multiple Myeloma (MM) will be treated with
Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA).
The safety profile of daratumumab to date, which does not appear to overlap with those known
for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of
daratumumab combined with various backbone regimens may improve the treatment effect of these
regimens. Additionally, daratumumab as a single agent may prolong the progression free
interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP,
there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing
regimen. This will be the first clinical trial to explore the feasibility of combining
daratumumab with a cyclophosphamide containing backbone induction regimen and if successful
will provide the rationale for larger studies exploring the efficacy of this combination in
greater detail.