再発または難治性骨髄腫におけるポマリドミド・シクロホスファミド・デキサメタゾン（PCD）療法とポマリドミド・デキサメタゾン（PD）療法の比較
基本情報
- NCT ID
- NCT03143049
- ステータス
- 不明
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 120
- 治験依頼者名
- National University Hospital, Singapore
概要
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.