During the latter months of 2017, the FDA has placed partial clinical holds on five trials and a full clinical hold on one trial of the PD-L1 inhibitor Durvalumab in combination with other immunomodulatory agents with or without chemotherapy in patients with multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or lymphoma.
The decision was based on risks identified in trials evaluating another PD-1 inhibitor, pembrolizumab, also being studied in combination with immunomodulatory agents in patients with MM.
This Trial has since been re-designed to be in the form of the IRIL study
Prospective, multicentre, open label trial, phase II study
Blood and bone marrow samples will be collected as part of the trial to assess the immunological, epigenetics and molecular profile
TRIAL PRINCIPAL INVESTIGATOR
Associate Professor Hang Quach
2017 – 2020
Newly diagnosed multiple myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant