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A prospective Phase II study of Durvalumab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma
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 

STUDY DESIGN

Prospective, multicentre, open label trial, phase II study 

CORRELATIVE STUDIES

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

TIME FRAME

2017 – 2020

SITE LOCATIONS

N/A

PARTICIPANTS

Newly diagnosed multiple myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant 

CURRENT ENROLMENT

N/A

STATUS

Withdrawn