Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA)

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.

Timeline

Start

2016-11

Primary completion

2018-09

Completion

2020-11

Publications

• O'Dwyer M, Henderson R, Naicker SD, Cahill MR, Murphy P, Mykytiv V, Quinn J, McEllistrim C, Krawczyk J, Walsh J, Lenihan E, Kenny T, Hernando A, Hirakata G, Parker I, Kinsella E, Gannon G, Natoni A, Lynch K, Ryan AE. CyBorD-DARA is potent initial induction for MM and enhances ADCP: initial results of the 16-BCNI-001/CTRIAL-IE 16-02 study. Blood Adv. 2019 Jun 25;3(12):1815-1825. doi: 10.1182/bloodadvances.2019000010.

Drugs

Indications