Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory Myeloma
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have
survival of less than 1 year. Recently, a randomized study of Pomalidomide and dexamethasone
conducted in compared with placebo and dexamethasone showed that pomalidomide can improve
survival of this group of patients. As a result, pomalidomide is now approved by the FDA and
EMA for use in patients with relapsed/refractory myeloma previously treated with bortezomib
and lenalidomide. We have conducted a study using Pomalidomide plus Dexamethasone (PD) in
Asian patients, which showed good efficacy and safety profile. More important for patients
with suboptimal response to PD will achieve a clinically meaningful response with the
addition of oral cyclophosphamide (PCD). In the United States, a small randomised phase 2
study of PCD versus PD showed that PCD have a higher response rates, produce deeper response
and correspondingly longer progression free survival. There is till date no randomised phase
3 study between these regimens. This will be important to determine what is the best
combination including pomalidomide for use in relapse myeloma.