Daratumumab, Thalidomide and Dexamethasone in Relapse and/or Refractory Myeloma
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have
survival of less than 1 year. A number of new drugs have been approved for the treatment of
relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib,
carfilzomib and Pomalidomide. However, most of these drugs either do not have good single
agent activity or still belongs to the category of immunomodulatory drugs or proteasome
inhibitors. Daratumumab is a monoclonal antibody against CD38 that is highly expressed on
myeloma plasma cells. In phase ½ studies, it has 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 outcome of patients with
myeloma. The use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been
shown to augment NK cell activity. NK cells are important mediator of antibody dependent
cellular cytotoxicity. We therefore hypothesize that the combination of Daratumumab with
thalidomide may therefore improve the efficacy of the treatment.
In this study, we will plan to perform a phase II trial using the Daratumumab, Thalidomide,
Dexamethasone combination in 100 myeloma patients with relapse myeloma in Asia.